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Co-host Ryan Piansky, a graduate student and patient advocate living with eosinophilic esophagitis (EoE) and eosinophilic asthma, and co-host Holly Knotowicz, a speech-language pathologist living with EoE who serves on APFED's Health Sciences Advisory Council, have a conversation about artificial intelligence (AI) and patient education, with guest Dr. Corey Ketchem, a third-year Gastroenterology Fellow at the University of Pennsylvania.   In this episode, Ryan, Holly, and Dr. Ketchem discuss Dr. Ketchem's interests, and his research into using an AI chatbot to provide patient education on eosinophilic gastrointestinal diseases. He shares, in broad terms, the methodology and conclusion of the research and what current and future research he is pursuing about using artificial intelligence to improve patient education and care.   Listen to this episode to learn about the current limitations and potential future benefits of using AI to help patients. Disclaimer: The information provided in this podcast is designed to support, not replace the relationship that exists between listeners and their healthcare providers. Opinions, information, and recommendations shared in this podcast are not a substitute for medical advice. Decisions related to medical care should be made with your healthcare provider. Opinions and views of guests and co-hosts are their own.   Key Takeaways: [1:17] Ryan Piansky and co-host Holly Knotowicz introduce the topic, artificial intelligence and patient education, and their guest, Dr. Corey Ketchem, a third-year Gastroenterology Fellow at the University of Pennsylvania.   [1:30] Dr. Corey Ketchem has an interest in allergic inflammation of the gastrointestinal tract, particularly eosinophilic gastrointestinal diseases (EGIDs), as well as artificial intelligence and epidemiologic studies.   [2:01] Dr. Ketchem did his residency at the University of Pennsylvania following medical school. There he met Dr. Evan Dellon, a world expert in EoE. Dr. Dellon became a mentor to Dr. Ketchem.   [2:24] As Dr. Ketchem learned more about EoE, he was fascinated by the many unknowns and opportunities for discovery within the eosinophilic GI field. He wanted to make an impact on patient care.   [2:51] Under Dr. Dellon's mentorship, he did epidemiologic studies. Seeking specialized training, he ended up at the University of Pennsylvania where he is getting rigorous training in epidemiology to study EGIDs.   [3:18] As ChatGPT was gaining its buzz, Dr. Ketchem saw a lot of clinical applicability. He views AI as an asset in epidemiology and hopes to use it to accelerate his research.   [4:30] AI usually references using computers to mimic human abilities, estimate decisions, or predict outcomes. An example is Natural Language Processing (NLP), to analyze and understand human language. Large Language Models (LLM) use NLP.   [5:08] ChatGPT is based on a LLM. LLMs use NLP techniques to understand vast amounts of text that they are trained on and generate responses in a chat format.   [5:25] Machine learning is another subset of AI that uses statistical techniques to give computers the ability to learn with the data and predict outcomes.   [5:50] The hope is to use these AI techniques to speed up discovery and also minimize human expense or labor.   [6:28] Dr. Ketchem co-authored a paper in Clinical Gastroenterology and Hepatology about an AI chatbot and EoE. He had been inspired by a cardiology paper on whether ChatGPT would create accurate, appropriate answers about cardiology disease health.   [7:19] Dr. Ketchem wondered if ChatGPT could be applied to EoE education. He discussed it with Dr. Dellon and Dr. Krystle Lynch, Dr. Ketchem's mentor at the University of Pennsylvania, and with Dr. Joy Chang, at the University of Michigan. They came up with a study design.   [8:06] The study asked ChatGPT questions about EoE, focusing on patient education and the therapeutics, and seeing if it gave accurate responses or not.   [8:45] The four doctors developed 40 questions that they gave ChatGPT as prompts and evaluated the responses. They proposed the questions in two ways: each question in an individual chat and 40 questions in a single chat.   [9:41] Analyzing the responses, the study demonstrated that ChatGPT responded with multiple inaccuracies to questions about EoE on general topics, complications, and management. Over half of the responses mixed correct and incorrect information.   [10:09] To evaluate the readability of the responses, the doctors used the Flesch-Kincaid reading ease tool. To understand the output from ChatGPT one would need high school and two years of college. That poses a potential health literacy barrier.   [11:40] The questions ranged from general: “What is eosinophilic esophagitis?”, to complications: “What is a food impaction?”, “What is a stricture?”, to therapeutics: “What are steroids for eosinophilic esophagitis?”, “Can I use a proton pump inhibitor for EoE?”   [12:15] It was not clear where ChatGPT pulled data from to respond to the questions. The data it was trained on was known to be in texts over a year old. Newer data may not have been accessible to ChatGPT.   [13:29] The doctors asked about things that were common knowledge in the eosinophilic GI realm, like dupilumab, and ChatGPT didn't know much about it because it was a newer treatment option for EoE at the time of the study. [13:42] The doctors scored the answers on their scientific accuracy and patient educational value. Simple questions got good responses. For questions about therapies and complications, “it wasn't doing well.” They identified limitations to the study. [14:14] The doctors asked ChatGPT if EoE is associated with cancer. From their best epidemiologic knowledge, the doctors don't think that it is. ChatGPT falsely associated EoE with esophageal adenocarcinoma.   [14:34] ChatGPT also associated EoE with Barrett's esophagus. To the doctors' best epidemiologic data, they are not sure that there's a connection.   [15:02] When the doctors asked the questions in individual chats, they asked ChatGPT for medical literature references for the information. It didn't provide accurate references. Titles and authors were often incorrect and links often didn't work.   [15:36] The incorrect references were a signal that ChatGPT wasn't ready to answer complex medical questions. In the more updated versions of ChatGPT, instead of giving references, it says you should consult your doctor, which is the right thing to do.   [15:56] The researchers concluded that implementing this technology requires clinical oversight; it's a tool that should be used with caution for patients in educating themselves and also from the perspective of a physician who is not an expert in EoE.   [16:29] Dr. Ketchem had been surprised by how long the responses were. He was expecting paragraphs but got pages and pages. He was also surprised by how quickly people were starting to use ChatGPT in other aspects of gastroenterology.   [16:57] While Dr. Ketchem and his team were writing the paper, another study came out about gastroesophageal reflux (GERD) that was somewhat similar to what Dr. Ketchem proposed for EoE. There is rapidly much being published about ChatGPT.   [17:14] Although the results were imperfect, there is potential applicability in patient-facing chats in the future for patient education but not yet there “for prime time.”   [18:33] These chats need to be transparent about where they're getting data, especially in the medical field.   [18:41] There will always be a role for people in medicine. You can't replace a face-to-face connection with a nurse or a physician with a chat bot.   [19:11] Dr. Ketchem says everyone needs to be careful about using AI tools. He advises patients to always discuss any medical questions with their physician. AI tools are not yet able to provide accurate medical information all the time.   [19:50] Ryan reminds listeners that this podcast is for educational purposes. Always consult your physician before making any changes to your healthcare. If you ask ChatGPT, also consult with your doctor before making any changes to your healthcare.   [20:31] One of the problems with large language models is the potential for inaccuracy. Dr. Ketchem's gold standard is the medical literature and you don't know where the large language models are getting their information.   [21:04] Future benefits may include helping patients get answers quicker and becoming more educated. Dr. Ketchem hopes we will get to a point where we can trust these technologies and implement them safely.   [21:37] Government organizations like the National Institutes of Health (NIH) and the U.S. Food & Drug Administration (FDA) are bringing together experts to think about large language models and create regulatory frameworks for their use in healthcare. Dr. Ketchem tells how HIPAA (Health Insurance Portability and Accountability Act) rules are followed to protect patients.   [23:29] Dr. Ketchem sees potential in machine learning to predict which therapies an EoE patient will respond to. AI is also used in colonoscopies to identify hard-to-see polyps. It might be useful in endoscopies to see changes in the esophagus from EoE.   [24:35] AI image recognition could also be applied in pathology. Dr. Ketchem is interested in trying to apply it to work he wants to do in the long term. People are working with pathology specimens to automate the counting of eosinophils. Dr. Ketchem discusses the potential use of AI for epidemiology in pathology.   [25:43] Dr. Ketchem and Holly discuss the potential for using AI chatbots in medical screening questionnaires. There will always need to be a human element.   [27:57] Dr Ketchem speaks to the potential future development of educational videos prepared by AI. It is a complex scenario that would require a lot of training. If a camera is added, AI could analyze where patients are having problems in taking medications.   [29:55] Dr. Ketchem says there are many moving parts in healthcare and many stakeholders, making it difficult to implement AI. It could be used in many aspects, but its use must be safe. Dr. Ketchem thinks it will soon be useful in medical imaging.   [30:57] In the next decade, AI may be used in drug discovery, clinical decision-making, and healthcare administrative operations. The goal is to improve the care for the patient. Personalized care would be an aspirational goal of using artificial intelligence.   [31:29] Dr. Ketchem heard of a computer scientist at a government meeting suggesting a far-future scenario of doctors having digital versions of patients to test the patient's reaction to a specific medication, based on comorbidities and other medications in use.   [32:30] Holly thanks Dr. Ketchem for sharing his research findings to help others.   [32:40] Dr. Ketchem's last words: “The future is bright. There are many open avenues to apply these technologies to eosinophilic GI diseases – in diagnostic support, personalizing treatment, and predictive modeling – to make patient care better.”   [33:10] Dr Ketchem is building a research program to use epidemiologic training with artificial intelligence. He hopes to find how to take text from histology or pathology and apply epidemiologic methods, to build a cohort of patients to study diseases faster.   [34:03] Dr. Ketchem hopes to use AI to help predict patient outcomes, regarding who will respond to what therapy and who will have more complications from their disease; those are things he is interested in. There are so many unanswered questions.   [34:30] After Dr. Ketchem finishes his fellowship, he hopes to be an independent investigator, being curious and answering these questions somewhere. If you know of such a job, please let Dr. Ketchem know!   [34:53] To learn more about Dr. Ketchem's research, please check out the links in the show notes. To learn more about eosinophilic gastrointestinal disorders, visit apfed.org/egids. If you're looking for a specialist who treats eosinophilic disorders, use APFED's Specialist Finder at apfed.org/specialist. [35:17] To connect with others impacted by eosinophilic diseases, please join APFED's online community on the Inspire Network at apfed.org/connections.   [35:26] Ryan thanks Dr. Corey Ketchem for joining us today. Holly thanks APFED's Education Partners, GSK, Sanofi, and Regeneron, linked below, for supporting this episode.   Mentioned in This Episode: Corey Ketchem, M.D., M.S. Penn Medicine Abstract of paper in Clinical Gastroenterology and Hepatology: “Artificial Intelligence Chatbot Shows Multiple Inaccuracies When Responding to Questions About Eosinophilic Esophagitis”Medscape article about the paper in Clinical Gastroenterology and Hepatology: “ChatGPT Gives Incorrect Answers About Eosinophilic Esophagitis”, by Carolyn Crist American Partnership for Eosinophilic Disorders (APFED) APFED on YouTube, Twitter, Facebook, Pinterest, Instagram Real Talk: Eosinophilic Diseases Podcast apfed.org/egids apfed.org/specialist apfed.org/connections   Education Partners: This episode of APFED's podcast is brought to you thanks to the support of GSK, Sanofi, and Regeneron.   Tweetables:   “We ultimately came to the conclusion that implementing this technology requires clinical oversight and it's a tool that should be used with caution.” — Corey Ketchem, M.D., M.S.   “There will always be a role for people in medicine. You can't replace a face-to-face connection with a chat. That's just not going to work.” — Corey Ketchem, M.D., M.S.   “There will always need to be a human element to it. The goal is to make [AI for healthcare] as good as it can be. We're certainly not there yet, but it's probably closer to being here than we think.” — Corey Ketchem, M.D., M.S.   Bio: Dr. Corey J. Ketchem, MD is a rising third-year gastroenterology fellow at the University of Pennsylvania, driven by a profound interest in allergic inflammation of the gastrointestinal tract, particularly eosinophilic gastrointestinal diseases (EGIDs). He has acquired a unique skillset in clinical epidemiology and biostatistics that equip him with the necessary tools to conduct rigorous research studies, culminating in a Master of Science in Clinical Epidemiology (MSCE) upon fellowship completion. Dr. Ketchem's passion for EGIDs has spurred a series of epidemiologic investigations focusing on both eosinophilic esophagitis (EoE) and non-esophageal EGIDs, yielding numerous publications in high-quality gastroenterology journals and earning him recognition through various research awards. Moreover, his academic path has included the incorporation of artificial intelligence into his research endeavors, aiming to enhance patient care and facilitate epidemiologic studies. Dr. Ketchem's trajectory is set toward becoming an independent researcher, dedicated to employing high-quality epidemiologic approaches to uncover pivotal insights into EGIDs, advance clinical knowledge, and optimize therapeutic strategies for patients.   Bio: Penn Medicine Division of Gastroenterology and Hepatology Fellows  

Episode 166: Naturopathic Medicine InsightsFuture Dr. Luong talked about what she learned about naturopathic doctors (NDs). She discussed the principles of naturopathic medicine and mentioned some differences in regulations across states in the US. Dr. Arreaza shared his opinion about the pros and cons of naturopathic medicine.  Written by Teresa Luong, MSIV, American University of the Caribbean. Comments and editing by Hector Arreaza, MD.You are listening to Rio Bravo qWeek Podcast, your weekly dose of knowledge brought to you by the Rio Bravo Family Medicine Residency Program from Bakersfield, California, a UCLA-affiliated program sponsored by Clinica Sierra Vista, Let Us Be Your Healthcare Home. This podcast was created for educational purposes only. Visit your primary care provider for additional medical advice.Arreaza: This may be a controversial topic. The term “natural” in medicine triggers strong reactions among allopathic doctors like me. Today we have a medical student who took up the challenge to talk about Naturopathic Doctors. Teresa:I am providing information based on research and living in Washington state, which is considered one of the birthplaces of modern naturopathic medicine, boasts the highest population of naturopathic doctors and a wide range of practice specialties. It's important to note that my responses are not personal opinions but rather informed insights. There are about 8,500 licensed naturopathic doctors in North America. Naturopathic Doctors may not use the title of physicians in California. What is a Naturopathic Doctor?While it's true that in California naturopathic doctors are not legally permitted to use the term ”physician” to describe themselves, some still choose to refer to themselves as “naturopathic physicians” colloquially or in their practice branding. So, confusion can arise because naturopathic doctors, while legally not recognized as physicians in California, can function as primary care providers, this overlap in roles can lead to the informal use of terms like ”naturopathic physician.“ However, it's important to recognize that legally, they are not recognized as physicians in this state. Naturopathic doctors (NDs) are healthcare professionals who embrace a holistic approach to healing, focusing on natural and non-invasive therapies to support the body's inherent ability to heal itself. Naturopathic medicine has its roots in traditional healing practices from around the world, blending ancient wisdom with modern scientific knowledge. The philosophy of naturopathy emphasizes the importance of treating the whole person—mind, body, and spirit—rather than just addressing isolated symptoms or diseases.What is an allopathic approach vs a holistic approach?Allopathic medicine: Allopathic medicine focuses on diagnosing and treating specific symptoms or diseases using pharmaceutical drugs, surgery, and other conventional interventions. Treatment is often targeted at managing symptoms or eradicating pathogens.Holistic medicine: Holistic medicine takes a broader approach, considering the whole person and aiming to address the root causes of illnesses. Treatment may involve a combination of conventional therapies and alternative modalities such as nutrition, herbal medicine, acupuncture, and lifestyle modifications. The focus is on promoting overall health and well-being rather than just treating isolated symptoms.Core Principles Naturopathic Practitioners: The six core principles of naturopathic medicine serve as guiding tenets for both diagnosis and treatment. These principles include: -first, do no harm. -the healing power of nature -identify and treat the root cause -treat the whole person, -the physician as a teacher; -and prevention as the best cure. Treatment modalities: Naturopathic doctors employ a wide range of therapeutic modalities to address the unique needs of each individual, such as:-Clinical nutrition, which focuses on using “food as medicine” to promote healing and prevent disease. -Herbal medicine utilizes the medicinal properties of plants to support various bodily systems and restore balance. -Acupuncture, everybody is familiar with acupuncture. -Other modalities may include hydrotherapy, homeopathy, physical medicine (such as massage and manipulation), and lifestyle counseling.The role of allopathic medications (NSAIDs, antibiotics) and surgical procedures.Naturopathic doctors typically prioritize natural therapies and lifestyle intervention, but may also integrate conventional medicine when necessary. Their views on traditional medications, such as NSAIDs, antibiotics, and surgical procedures vary depending on the individual practitioner and their approach to healthcare. Some may recommend them when appropriate, while others may prefer to explore alternative options first. Ultimately, their goal is often to promote holistic health and well-being. Education and Training: Pre-Medical Requirements: Aspiring naturopathic doctors typically complete undergraduate coursework in pre-medical sciences, including Biology, Chemistry, Physics, and Psychology.Naturopathic Medical Program:Naturopathic doctors must graduate from a four-year accredited naturopathic medical school. The forst two years are basic sciences courses and the last 2 years are clinical courses.After completing their naturopathic medical education, graduates must pass the Naturopathic Physicians Licensing Examinations (NPLEX) to become licensed practitioners. MDs need a residency, and NDs can start working immediately after school in some states, or they can do some additional training.Scope of Practice: The scope of practice for naturopathic doctors varies depending on the regulations in each jurisdiction. In general, NDs are trained to:- Prescribe natural therapies such as nutritional supplements, herbal remedies, and homeopathic medicines.- Prescribe prescription medications, including some, but not limited to, controlled substances.- Provide dietary counseling and lifestyle interventions tailored to individual health needs.- Provide Primary Care, such as, performing physical exams, administering vaccinations, ordering laboratory tests,- Offer acupuncture.- They can use detoxification protocols and intravenous (IV) nutrient therapy into treatment plans.- Utilize mind-body techniques like meditation, mindfulness, and relaxation exercisesIn January 2022, the recognition of naturopathic doctors (NDs) and the extent of their scope of practice vary significantly from state to state within the United States. Here's an overview of states where NDs are recognized and their scope of practice:Licensed States: In these states, naturopathic doctors are licensed to practice independently and have a broad scope of practice, including diagnosis, treatment, and prescription of medications and natural remedies within their scope. Some states may have specific restrictions or additional requirements.-California: NDs are licensed and regulated by the California Naturopathic Medicine Committee. They have a comprehensive scope of practice, including the prescription of certain medications.-Washington: NDs are licensed and regulated by the Washington State Department of Health. They have a limited formulary for prescription medications.Unlicensed States (for example, Georgia and Virginia): In states where naturopathic medicine is not regulated, NDs have to work as healthcare consultants or working alongside other licensed healthcare providers, like MDs. The scope of practice in these states may be more limited, and NDs may not have the authority to diagnose, treat, or prescribe medications independently.Pros:Naturopathic doctors utilize natural and holistic therapies, which may have fewer side effects compared to conventional medications. These therapies can complement conventional treatments, especially if they are collaborating with an MD.If Naturopathic doctors work collaboratively, it can offer complementary care options to patients, which can provide patients with treatment modalities and perspectives beyond conventional medicine. This can be particularly beneficial for patients who are a bit apprehensive to traditional medicine for whatever reason.Naturopathic medicine emphasizes preventive care and strategies to promote health and prevent disease. So they try to catch underlying imbalances and risk factors early, and see patients multiple times a week, which can help patients reduce their risk of developing chronic illnesses and improve their overall quality of life. By seeing a patient this frequently, it promotes stronger doctor-patient relationships and improves patient satisfaction.Cons:Lack of Regulation and Standardization: Naturopathic medicine is not regulated to the same extent as conventional medicine, and there may be variability in the education, training, and qualifications of naturopathic doctors. This lack of regulation and standardization can raise concerns about the quality and safety of naturopathic care.Limited Scientific Evidence: Some naturopathic treatments  lack rigorous scientific evidence supporting their efficacy and safety. Without robust clinical research, it can be challenging to assess the effectiveness of certain naturopathic interventions and differentiate between evidence-based practices and unproven therapies.Potential for Harmful Practices: In some cases, naturopathic doctors may recommend treatments or interventions that have the potential to be harmful, particularly if they lack scientific support or are based on unfounded beliefs. Patients may be at risk of receiving ineffective or unsafe treatments without proper oversight and regulation.Delayed Access to Conventional Care: So if a patient relies solely on naturopathic care, it may delay access to conventional medical treatments that are necessary for managing serious or life-threatening conditionsCost and Insurance Coverage: Naturopathic services may not be covered by health insurance plans, or coverage may be limited compared to conventional medical services. This lack of insurance coverage can make naturopathic care inaccessible to some patients, particularly those with limited financial resources.This information is provided to increase your knowledge on this topic, it is not intended to convince you to go against or support naturopathic medicine. Our goal is to inform you and you can draw your own conclusions about it. It is important to educate ourselves on this topic because naturopathic doctors are rising in California and we may encounter them in our future practices. ________________________________Conclusion: Now we conclude episode number 166, “Naturopathic Medicine Insights.” Future Dr. Luong explained that naturopathic doctors receive training in naturopathic medical schools and receive a degree before they sit for a board exam. Many NDs may be working in outpatient primary care or even in hospital care. Dr. Arreaza shared his opinion about the pros and cons of having naturopathic medicine available for patients.This week we thank Hector Arreaza and Teresa Luong. Audio editing by Adrianne Silva.Even without trying, every night you go to bed a little wiser. Thanks for listening to Rio Bravo qWeek Podcast. We want to hear from you, send us an email at RioBravoqWeek@clinicasierravista.org, or visit our website riobravofmrp.org/qweek. See you next week! Links: American Association of Naturopathic Physicians:aanp.org. Complementary, Alternative, or Integrative Health: What's In a Name? NIH National Center for Complementary and Integrative Health, https://www.nccih.nih.gov/health/complementary-alternative-or-integrative-health-whats-in-a-name. Accessed March 21, 2024. Bastyr University:bastyr.eduNational University of Natural Medicine (NUNM):nunm.eduFleming SA, Gutknecht NC. Naturopathy and the primary care practice. Prim Care. 2010;37(1):119-136. doi:10.1016/j.pop.2009.09.002. https://pubmed.ncbi.nlm.nih.gov/20189002/Atwood KC 4th. Naturopathy: a critical appraisal. MedGenMed. 2003;5(4):39. Published 2003 Dec 30. https://pubmed.ncbi.nlm.nih.gov/14745386/Public Notification: Artri King contains hidden drug ingredients, U.S. Food & Drug Administration (FDA), April 20, 2022. https://www.fda.gov/drugs/medication-health-fraud/public-notification-artri-king-contains-hidden-drug-ingredientsRoyalty-free music used for this episode: My Dinner with the Diablo by Tropicalia, downloaded on July 20, 2023 from  https://www.videvo.net/. 

Hello, I hope everyone is having a blessed week! Today I am interviewing Kim Collins. Kim Collins is , married to Bruce L. Collins Sr. for 28 years, mother of four young adults attends United Love church with Pastor Larry Stewart and is a graduate of Morgan State University with a bachelor's degree in Medical Technology & Public Health. Kim is currently employed with the Food & Drug Administration (FDA), Office of Regulatory Affairs as a Consumer Safety Officer. Kim has served the federal government for the past 23 years, with most of her career with the National Institutes of Health (NIH). Positions held during federal tenure have included, Team Leader, Department of Laboratory Medicine (NIH), Scientific Reviewer with Center for Devices & Lead Project Manager, Center for Tobacco Products (FDA). Kim is also a member of the Loudoun County (VA) Chapter of The Links, Incorporated and the founder and CEO of Pearls Empowerment, Inc., a non-profit faith-based mentoring program for girls & women. Pearls mission is Preparing, Equipping, Affirming, and Renewing young Ladies for Success! As a faith-based program, our goals are to use Biblical principles to encourage & equip each girl. We strive to meet girls “where they are” in their unique growth & development, cultivating confidence along the way. The process varies for each girl and the result is priceless, precious, valuable & irreplaceable. Pearls is a year-round program offering workshops & various initiatives revolving around a variety of themes including but not limited to: purity, leadership, self-esteem, self-awareness, mentoring, understanding their value, college readiness, culinary arts, civic engagement, STEM, life skills, etc.   Contact Her: Kim Collins Founder, Executive Director | Pearls Empowerment, Inc.703.439.0711 pearlsempowerment.org

The Medical Alley Association and its partners, Investissement Quebec and the Quebec Government Office in Chicago, present a seminar preparing new market entrants for global regulation and U.S. reimbursement. Medical Devices and Digital Health products face a range of regulations in the United States, primarily from the Food & Drug Administration (FDA). Further, reimbursement, or payment for various health services, in the U.S. differs significantly compared to most other countries. A mix of public and private, national and regional, and separate of medical, dental, vision, and pharmacy benefits means your path to securing payment can be complex and fraught with risk. In this session you will learn the latest on FDA regulations and strategies to employ in launching your first product in the U.S. as well as the fundamentals of U.S. reimbursement and how to pursue it for your company. We were joined for this webinar by Kirk Honour and Joseph Sierra of NAMSA, who offered their insights on the regulatory hurdles and reimbursement issues companies should consider when entering the U.S. market.

INGREDIENTS OF THE DAY:  none How do new food additives make it into the food supply?  They have to get a nod from the Food & Drug Administration (FDA).  In this episode, we take a look at the FDA review process and then examine a handful of proposed additives in the FDA queue to see what may show up in the processed foods of the future. Show Notes: To Contact Show:  foodlabelsrevealed@gmail.com Facebook Page:  https://www.facebook.com/prophetofprocessedfood/?ref=bookmarks The podcast can be subscribed to at the iTunes store, or Google Play, or using most of the podcast apps available for smart phones or tablets.  Just search under Food Labels Revealed. References: Substances Added to Food https://www.cfsanappsexternal.fda.gov/scripts/fdcc/?set=FoodSubstances GRAS Notices https://www.cfsanappsexternal.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices Music: Intro music is the "Peter Gunn Theme" by Henri Mancini. Outro music is “Bright Wish” courtesy of Kevin McLeod

Il Canada ha già autorizzato il vaccino Pfizer-Biontech per gli adolescenti tra i 12 e i 15 anni, mentre negli Stati Uniti il responso della Food & Drug Administration (Fda) è atteso entro qualche giorno. Anche l'Europa potrebbe procedere nella stessa direzione nel giro di poche settimane. Intanto, procedono i test anche per le fasce di età sotto i 12 anni; l'obiettivo delle case farmaceutiche è arrivare a coprire con il vaccino anti-covid19 tutta la popolazione a partire dai sei mesi di età. Restando in tema di neonati, anche gli Stati Uniti, come l'Italia, registrano un calo delle nascite mai visto dal 1979 in qua. E' un altro degli effetti collaterali del Covid, per l'incertezza economica e lavorativa provocata a livello diffuso dalla pandemia. In Italia a gennaio si è registrato un calo delle nascite di oltre il 14% e le stime fino all'autunno non sono più rassicuranti. Del forte calo delle nascite si preoccupa anche Papa Francesco, che aprirà venerdì prossimo, 14 maggio, gli Stati generali della natalità.

In 2013, Texas implemented a slew of laws targeting abortion providers, shuttering over half of the state’s 40-some clinics overnight. The founder, CEO, and president of one such clinic, Amy Hagstrom Miller of Whole Woman’s Health, felt she had no option other than to sue the state to protect Texans’ right to choose. Still, as the now-landmark case Whole Woman's Health v. Hellerstedt wound its way through the federal court system, she was commonly asked the question: “Are you ready to risk the abortion rights of the whole country?” Bringing a case to the Supreme Court can lead to a Roe v. Wade-level decision — expanding rights for the entire nation — or the opposite. Nine years later, and with three reproductive rights cases currently in the federal court system, Hagstrom Miller finds herself in a situation with similarly high stakes. Though the Supreme Court said access to safe, legal abortions was a constitutional right 48 years ago, the anti-choice movement has steadily chipped away at the protections enshrined in Roe through restrictions and bans. The October SCOTUS confirmation of Justice Amy Coney Barrett, who is publicly anti-choice, was another blow to the reproductive rights movement, advocates said at the time. Says Hagstrom Miller, “You have to ask, ‘What advancements or rollbacks could happen?’” if the court rules one way or the other. But while bringing cases to SCOTUS was one of the only ways to protect national access under President Trump and a Republican-dominated Congress, a lot has changed in just three months. With the inauguration of President Joe Biden in the bag, pro-choice groups are gearing up to not just preserve the status quo, but expand abortion access — and rights — nationwide. “We’ve long known that the promise of Roe v. Wade was never real for working families in America,” Kelsey Ryland, co-director of All* Above All, a reproductive justice policy and strategy organization, tells Bustle. That’s why, she adds, now’s the time to “re-imagine” what Roe can do for people. “The courts are one piece of protecting access to abortion care, but they’re not our saving grace.” Below, four reproductive rights advocates explain what their biggest priorities are for the next four years. A major first step to expanding reproductive health care access in the United States independent of the court system would be repealing the Hyde Amendment, the annual budget bill rider that bars federal funds from paying for abortions. Under Hyde, people enrolled in Medicaid can’t use that health insurance for terminating a pregnancy, except in limited cases. This budget detail keeps the poorest Americans from receiving the same health care that their wealthier, privately insured peers have. Without insurance coverage, a first-trimester abortion costs about $500 in the United States just for the procedure; many clinics charge up to $250 in additional fees. The Biden administration has pledged to remove abortion coverage bans like Hyde from the budget, and a slim Democratic majority in both the House and Senate mean that it’s possible. But Ryland stresses that Hyde is just one piece of the puzzle. Earlier this month, All* Above All released a policy proposal that would holistically address how economic marginalization keeps people from getting comprehensive reproductive care. In addition to ending Hyde, the proposal points to raising the federal minimum wage to $15 an hour, ending tipped wages, protecting essential workers from deportation, and including low-wage workers in economic recovery efforts as actions the Biden-Harris administration can take in their first 100 days. “We have a great opportunity with the new administration and we’re really calling on the Biden-Harris administration to build back bolder,” Ryland says. “This is what we mean when we say that Roe was never enough. People need comprehensive and bold solutions to thrive and get the care they need.” Yamani Hernandez, the executive director of the National Network of Abortion Funds, echoes the need for Hyde repeal, but adds that there are many more costs that go into terminating a pregnancy. That’s why Hernandez’s organization has focused their past year on implementing a process to pool together funds, in preparation for whatever changes SCOTUS’s conservative supermajority might bring. Abortion funds help people afford both the procedure and associated expenses, like lodging, gas money, or child care. Hernandez explains that most funds aren’t able to pay for the full cost of an abortion for every person who calls. Generally, they’ll make a pledge of a certain dollar amount, and then refer the patient to other funds that might be able to help contribute the rest, so that the patient effectively crowdfunds their abortion. “We want to close that gap so people don’t have to call around to five different funds to get $50 here, $200 there,” says Hernandez. “On average, an abortion fund is able to fund about 1 in 4 people who call. We want to raise enough money to make those budgets higher.” The fund pooling program is now being piloted in certain regions of the country. The patient gets matched with a full-time staff case manager who will follow them throughout the process, taking the work of calling different funds off their plates. The Supreme Court's conservative supermajority undertook its first decision on abortion access in early January, when it approved a Trump administration request to reinstate restrictions on medication abortion that had been temporarily lifted because of the pandemic. Now, patients have to pick up mifepristone in-person (even though you take it at home), rather than have it mailed to them. Decisions like these explain why Kirsten Moore, the director of the Expanding Medication Abortion Access (EMAA) Project, has always focused on swaying Food & Drug Administration (FDA) policy, rather than trying to make change through legislation. Ultimately, it comes down to one FDA program, called Risk Evaluation and Mitigation Strategies (REMS), that regulates high-risk drugs like chemo medication to ensure they’re used safely. Mifepristone, however, is safer to take than a Tylenol, and unlike chemo drugs, is taken at home. “The Biden-Harris administration needs to speak up early and indicate their concern with the Supreme Court decision … [and] encourage the FDA to undertake a full review of the REMS,” Moore says. She hopes that without fear of pushback from the Trump administration about mifepristone’s regulations, the FDA will be ready to re-evaluate how patients can get this medication. Another crucial way to work around the Supreme Court? Change hearts and minds on the ground. “If we could have a shift in Texas like what has happened in Georgia, we could stop these laws from getting into the court system altogether,” says Hagstrom Miller. “It’s a lot cheaper to block a law from being passed in the first place than to block a law from going into effect [...] and that would be more powerful and more long-standing than any given court case.” Rachel Rebouché, the associate dean of research and James E. Beasley Professor of Law at Temple University, adds that the pandemic has changed how people have become accustomed to seeking out care. “Virtual clinics, online pharmacies, patients having medication abortion mailed to them — this all is about to become even more important now” that the FDA restrictions on mailing medication abortion pills are back in place, but the pandemic continues on. Rebouché is optimistic that no matter what policy changes get made, patients and providers will step in to fill the gaps. “There will become abortion markets that try to meet the needs of abortion deserts. That will have costs. People will travel. Self-managed abortion will jump and there will be consequences. But there will also likely be [financial] incentives to build out ways to support these markets, and I do think that’s where people are looking right now,” she says. “If you can’t rely on the Supreme Court and the Constitution for protection, then state regulations, federal actions, informal networks, and service infrastructure has to be the way to go.”

Just days after it was authorized for emergency use by the Food & Drug Administration (FDA), the first doses of Pfizer’s COVID vaccine have been delivered to healthcare workers across the U.S. Dr. Beth Oller, M.D., 40, a family physician in Stockton, Kansas, received her shot on Dec. 18. Here, she tells Bustle about combating misinformation and what getting her first dose was like. The vaccine is my favorite Christmas present I’ll get this year. I’ve never been excited to get a shot before, but this one truly is exciting. My community is very small and rural, and we didn’t know if we would get vaccines in the first wave or not. So we feel very fortunate to have gotten doses this week. It felt the same as getting the flu shot: a little bit of pain when it went in, but that was it. About two hours post-vaccine, I'm feeling fine, with no reactions yet. I am definitely less afraid of possible vaccine side effects than I am of the possible post-COVID symptoms. I tell my patients to look at the positives: the vaccine's side effects mean their body is doing its job! I got vaccinated on Facebook Live, then stayed online for another 15 minutes answering vaccine questions: “Did the FDA cut corners on safety?” “Are there microchips in these?” As they’re asking, they’re saying, “I don’t think this is true, but…” There’s so much misinformation out there right now. I don’t want to label any question as too silly, because if someone is asking, it means other people have the same question. Frontline healthcare workers — physicians, scientists, epidemiologists, immunologists — are not the kind of people who’ll follow anything blindly. I'm trying to ease people's minds that when I made the decision to be vaccinated, it wasn't just out of blanket trust of the medical establishment. It’s OK to ask questions about something you’re going to put into your body, but researchers have been able to vet this and are not only confident about but excited to get this vaccine. People have asked if I would get it if I were pregnant, and I said absolutely — and I’d feel awesome about it. I’m breastfeeding and I didn't hesitate to get it. In the beginning of the pandemic, when medical professionals were trying to put out information about masking and social distancing, there was so much fear, so much we didn't know about the virus. But as the pandemic’s gone on, there was also a feeling of defeat among healthcare providers, because nobody was doing what they were supposed to. I kept thinking, “When people start dying, everyone else will start wearing masks.” It never did — not when the first deaths happened, not when the schools closed. In my county, we didn’t opt into a mask mandate until just a couple of weeks ago, and, from what I’ve seen, it hasn’t changed mask-wearing at all. I try to use an analogy that I’ve seen to describe how the pandemic will end. The pandemic right now is a fire, and the vaccine is a very powerful firehose, but the effectiveness of that hose has to do with the extent of the fire. One fire hose doesn't do a lot to a forest fire, but lots of hoses together do better. Being able to get the vaccine today is history, but in my life, nothing will change. I will keep doing everything I’m doing right now to protect others from COVID — wearing a mask, social distancing. Researchers still don't know if the vaccine keeps people from being asymptomatically infected and potentially spreading the virus, so my diligence has to stay the same. And I'm OK with that. I will continue to preach taking these precautions and the importance of getting vaccinated — for as long as it takes. This interview has been edited and condensed for clarity.

Tami Wahl, Strategic Policy Advisor in Washington, D.C. with Market Access Today joins us today to talk about Sound policy solutions in cannabis. With over twenty years of legal and legislative experience, Tami Wahl is proud to represent forward-thinking clients from a diverse business landscape. Innovators from Hemp, Wearable Tech, Fashion Tech, Banking, FinTech, Cannabis, and other industries have made Tami Wahl the voice for their cause in Washington, D.C. Ms. Wahl also works with industry stakeholders, trade groups, Congressional members, and federal agencies on both sides of the aisle to drive sound policy solutions and ultimately, create a balanced pathway to market for innovative products. Ms. Wahl started her legal career in private practice as a criminal defense counsel in Austin, Texas, and for the past 10 years, she has worked as legislative and regulatory counsel, General Counsel, and In-House Counsel for entrepreneurs, and small-to-medium size companies. Ms. Wahl has expertise in working with the U.S. Food & Drug Administration (FDA), U.S. Department of Agriculture (USDA), Federal Trade Commission (FTC), and Customs and Border Patrol (CBP). Ms. Wahl has spoken nationally on issues germane to her work and is committed to realizing the successful intersection of consumer safety with appropriate agency oversight and uninhibited innovation.

Marijuana as of 2020 is now legal in 15 states in the United States. CBD products are popping up in can drinks nearly every where you look these days. Is it legal? Can cider now be fused with cider or at least CBD or perhaps THC? Find out in this special presentation prerecorded at CiderCon2020. Opening slide to: Current regulatory status of marijuana and CBD beverages Presentors Attorney Marc Sorini and Attorney Alva Mather of McDermott Will & Emery LLP Marc Sorini Alva Mather Topics presented: How The Controlled Substance Act (CSA) impacts marijuana use. Status of marijuana Under Federal Law The politics and law relating to cannibus The Cole Memo during the Obama Administration running through the Trump administration Appropriation restrictions affecting marijuana law Tetrahydrocannabinol (THC) vs Cannabidiol (CBD) Industrial Hemp Agricultural Act of 2014 (2014 Farm Bill) vs Agriculture Improvement Act of 2018    (2018 Farm Bill) Former Commissioner Gottlieb statement in 2018 and its impact on FDA regulations How the Food Drug Administration(FDA) and the Alcohol and Tobacco Tax and Trade Bureau (TTB) work together regulation cider Is marijuana Generally Recognized as Safe (GRS) by the FDA? What is the enforcement concerning CBD products? What does the future hold for having THC in cider? Why labeling (COLA) counts! From the presenter's presentation: TTB has made it clear that it will not approve any formula for a product containing a Schedule I controlled substance TTB has also made it clear that it has conferred with FDA and will not approve a formula for a product containing ingredients not recognized as GRAS   Help Support Cider Chat Please donate today. Help keep the chat thriving! Find this episode and all episodes at the page for Cider Chat's podcasts. Listen also at iTunes, Google Play, Stitcher (for Android), iHeartRadio , Spotify and wherever you love to listen to podcasts. Follow on Cider Chat's blog, social media and podcast Twitter @ciderchat Instagram: @ciderchatciderville Cider Chat FaceBook Page Cider Chat YouTube

When it comes to food, knowing what you're getting can be tricky. On the surface, words such as “pure” and “natural” seem straightforward, yet defining them in the modern world has required experts, laws, and administrative structures. In this episode, Bob & Ben speak with Lafayette College's Benjamin Cohen about the pure food crusades of the late nineteenth century, the origins of the Pure Food Act of 1906 and the Food & Drug Administration (FDA), and the lessons this era offers us as we seek to make decisions about food policy in the 21st century. Dr. Benjamin R. Cohen is Associate Professor of Engineering Studies and Environmental Studies at Lafayette College and the author of Pure Adulteration: Cheating on Nature in the Age of Manufactured Food (University of Chicago Press, 2019). Learn more about his work at his personal website or by following him on twitter at @BRCohen95. This episode was edited by Gary Fletcher. Join Bob & Ben for a live podcast recording! Click here for dates and ticket links.

Today we have a special JIMMY RANTS on The LLVLC Show for you. Jimmy is on his much deserved six-month sabbatical so we are bringing you some of the best content from Jimmy’s daily show JIMMY RANTS. Be sure to bookmark JimmyRants.com and dig through all of the content there during Jimmy’s time away. Paid advertisement “I wonder if we are training our brains to continue the sugar addiction we are trying to overcome by continuing to use these products.” Jimmy Moore Paid advertisement There’s a new sweetener that’s all the rage in the keto community because it supposedly doesn’t raise blood sugar and insulin levels. It’s called allulose and it’s got the taste and cooking properties of real sugar without the calories or negative effects on your health. The Food & Drug Administration (FDA) just issued their heralded GRAS (generally recognized as safe) status to this sweetener. Read all about this news that will open the floodgates to new low-carb food products hitting the market in the next year below. FDA guidance could prompt surge of interest in low-cal, tooth-friendly, rare sugar allulose: https://www.foodnavigator-usa.com/Art… This is a double-edged sword for health podcaster and international bestselling author of KETO CLARITY Jimmy Moore who says while this is good news for people wanting something sweet, having more sweet treat options might not be the answer. Listen to Jimmy share his thoughts about this new development and what it means for the ketogenic community in this episode.

There's a new sweetener that's all the rage in the keto community because it supposedly doesn't raise blood sugar and insulin levels. It's called allulose and it's got the taste and cooking properties of real sugar without the calories or negative effects on your health. The Food & Drug Administration (FDA) just issued their heralded GRAS (generally recognized as safe) status to this sweetener. Read all about this news that will open the floodgates to new low-carb food products hitting the market in the next year below. FDA guidance could prompt surge of interest in low-cal, tooth-friendly, rare sugar allulose: https://www.foodnavigator-usa.com/Art... This is a double-edged sword for health podcaster and international bestselling author of KETO CLARITY Jimmy Moore who says while this is good news for people wanting something sweet, having more sweet treat options might not be the answer. Watch Jimmy share his thoughts about this new development and what it means for the ketogenic community in this video. Follow the live JIMMY RANTS episodes on his YouTube Live channel (http://www.youtube.com/livinlowcarbman), his Facebook Live channel (https://www.facebook.com/livinlowcarbman), and his Instagram Live channel (http://www.instagram.com/livinlowcarbman) airing daily (rotating around these various formats) and the rest of his work at http://www.LLVLC.com. And for more JIMMY RANTS, check out all of his past episodes at http://www.JimmyRants.com.

Desde Ciencia Forense hasta los efectos de la marihuana en el sistema inmune, estas son algunas de las experiencias de laboratorio de nuestra invitada, la Dra. Julie Castañeda. Nacida en New York pero criada en Guatemala, la Dra. Castañeda nos brinda una perspectiva diversa de sus experiencias en el campo de las ciencias en el mundo académico, en la industria y en su nuevo empleo en el Food & Drug Administration (FDA) donde tiene un rol vital en el proceso de aprobación de nuevas drogas para enfermedades en los Estados Unidos. En esta conversación también hablamos de las dificultades durante sus comienzos en escuela graduada y cómo logró superarlas. También compartimos recursos y los programas de los que platicamos. Espero que sea útil para todos ustedes que están por comenzar sus carreras científicas, que se lo disfruten!

The two largest determinants of health are the zip code and credit scores. What does that have to do with precision medicine and genetics? Big data combined with AI hold a lot of hope on prevention and more effective disease treatments. The current reality though is that large a lot of gathered data is not actionable yet. How far is precision medicine then, today? How does precision medicine based medical care look like? Tune in episode 9 of Faces of digital health with dr. Subha Madhavan. Dr. Madhavan is the Director of the Innovation Center for Biomedical Informatics (ICBI) at the Georgetown University Medical Center in the States. She is active in several national and international research projects, and one of her latest projects is a partnership with the Food & Drug Administration (FDA) to develop evidence bases for pharmacogenomics and vaccine safety. 

In this episode, Erica Jackson discusses recent guidance from the Food & Drug Administration (FDA) on the consideration of real-world data and real-world evidence in regulatory decision-making related to medical devices and their development. The episode notes stakeholders should work closely with the FDA so that real-world data collected and maintained during the development process is high quality, relevant, reliable, and stored with the appropriate privacy and data security protections.  Presenter: Erica M. Jackson Download Presentation Materials

Online platforms need well-crafted stories to connect their ideas with people who are listening, reading, or watching. And crafting a story is just that—a craft. As with any craft, it takes time to develop and practice to perfect. Master storyteller Beth Kapes is an award-winning content creator. Her business, Moving Words Into Action, has helped clients tell stories that make a difference for over 20 years. She has developed content for national corporate and not-for-profit institutions, publishing groups, and websites. Her clients have included WebMD, the Food & Drug Administration (FDA) and the National Institutes of Health (NIH). She has authored two historical perspectives for the Fortune 200 company, Parker Hannifin Corporation. And that’s not all! Most recently, she served as the managing editor for the 2016 Republican National Convention. Follow along as Beth reveals her secret to generating ideas, getting organized, and making a piece of content that’s fresh, valuable, and engaging. In This Episode How to prepare to create different types of content Steps to making complex, bland topics more sexy Where to go to generate your best ideas Tools for making stories feel fresh and unique How to fit content creation into your day, every day Resources Beth Kapes on LinkedIn and Twitter Moving Words Into Action The Synonym Finder The Cooper Hill Stylebook Seth Godin’s blog Backwards in High Heels: The Impossible Art of Being Female by Tania Kindersley and Sarah Vine

Mary Logan, President and CEO of the Association for the Advancement of Medical Instrumentation (AAMI), stops by to discuss the past, present and future of this progressive and proactive organization.  Since 1967, AAMI has been the primary source of consensus and timely information on medical instrumentation and technology.  Mary also introduces us to the Healthcare Technology Safety Institute, an AAMI partnership with the Food & Drug Administration (FDA), which endeavors to tackle current and pressing issues surrounding medical instrumentation.  She then goes on to build excitement for AAMI’s upcoming annual conference, as well as imparts a surprising but important life lesson.