Podcast appearances and mentions of darshan kulkarni

When are you obligated to disclose information about your business to the buyer? In this episode, attorney Darshan Kulkarni emphasizes the need to understand risk and be transparent about material information.  View the complete show notes for this episode.  Want To Learn More?  Negotiating an M&A Purchase Agreement | M&A Tips M&A Due Diligence | Checklist & Overview The Role of M&A Lawyers When Selling Your Business Additional Resources: Selling your business? Schedule a free consultation today. Download The Art of The Exit: The Complete Guide to Selling Your Business Download Acquired: The Art of Selling a Business With $10 Million to $100 Million in Revenue If you have any topic or guest suggestions, please email them to podcast@morganandwestfield.com.  

Join AFS Life Sciences Partner Stephanie Trunk and Darshan Kulkarni, Life Sciences regulatory and compliance attorney, as they explore the major shifts occurring in the pharmaceutical industry under the Trump Administration. Highlights of the conversation include: Evolving regulations for off-label pharmaceutical promotion. Enhancing a firm's global footprint by building trust with sovereign governments. Examining new compliance challenges stemming from AI technology. Navigating US Food and Drug Administration guidance as an unreliable indicator of enforcement priorities. Increasing scrutiny of the role of medical affairs. Finding balance between patient access and regulatory compliance.

In this special episode of This Week in Pharmacy, we dive into one of the most debated topics in healthcare today: GLP-1 receptor agonists. Joining the discussion are Josh Pirestani, Editor-in-Chief of Dispense Times; Dr. Darshan Kulkarni, PharmD, of Kulkarni Law Firm; and Dr. Masoud Rashidi, PharmD, FAPC, CEO of Innovative Compounding Pharmacy. Whether you see the latest weight loss drugs as a miracle or a menace, the hype around GLP-1s is impossible to ignore. What started with Ozempic, a diabetes treatment, quickly shifted into a global weight-loss trend. Soon after, Wegovy, a high-dose version officially marketed for obesity, took center stage. The popularity of these medications skyrocketed, catapulting their manufacturer's market value beyond the entire economy of Denmark. And now, Eli Lilly's Zepbound has entered the competitive landscape. Our expert panel explores the current state of GLP-1s, discussing: ✅ The clinical impact and efficacy of these drugs ✅ Safety concerns and side effects ✅ Ethical considerations surrounding off-label use ✅ The skyrocketing demand and supply shortages ✅ How compounding pharmacies are navigating the GLP-1 surge With soaring demand and increasing controversy, the conversation around these medications is far from over. Tune in for an insightful discussion on what's next for GLP-1 receptor agonists and the future of weight loss treatments.

Starting a new business, or even if you're already in business, legal matters can often be overlooked. While there are potential challenges, with a little preparation and proper legal guidance, you can avoid many common pitfalls. As a business owner, it's essential to have both a good accountant and a reliable lawyer on your team. Darshan Kulkarni helps small and medium-sized healthcare and life sciences businesses navigate corporate law and regulatory challenges. As the Principal Attorney of the Kulkarni Law Firm, he provides practical legal solutions, from FDA compliance to contracts and M&A support. Darshan's clients include pharmacies, telemedicine providers, and biotech companies looking to grow while managing regulatory risks. Known for his clear guidance and strategic approach, Darshan simplifies complex legal issues so businesses can focus on innovation and growth. Hosted by Benny Carreon and Dennis Jackson Darshan Kulkarn-kulkarnilawfirm.com Benny Carreon- Velocity Technology Group- benny@velocitytechnology.group;https://velocitytechnology.group/ Dennis Jackson-WorX Solution- dennisj@worxsolution.com ; www.worxsolution.com

Starting a new business, or even if you're already in business, legal matters can often be overlooked. While there are potential challenges, with a little preparation and proper legal guidance, you can avoid many common pitfalls. As a business owner, it's essential to have both a good accountant and a reliable lawyer on your team. Darshan Kulkarni helps small and medium-sized healthcare and life sciences businesses navigate corporate law and regulatory challenges. As the Principal Attorney of the Kulkarni Law Firm, he provides practical legal solutions, from FDA compliance to contracts and M&A support. Darshan's clients include pharmacies, telemedicine providers, and biotech companies looking to grow while managing regulatory risks. Known for his clear guidance and strategic approach, Darshan simplifies complex legal issues so businesses can focus on innovation and growth. Hosted by Benny Carreon and Dennis Jackson Darshan Kulkarn-kulkarnilawfirm.com Benny Carreon- Velocity Technology Group- benny@velocitytechnology.group;https://velocitytechnology.group/ Dennis Jackson-WorX Solution- dennisj@worxsolution.com ; www.worxsolution.com

In this episode, Edye Edens and Darshan Kulkarni discuss the evolving landscape of IRB oversight in 2024, including the roles of HRPP, AAHRPP, and OHRP, and the need for greater federal agency involvement. They also cover the impact of new guidance, the Trump administration, and the FDA's relationship with IRBs.We discuss: 1. The FDA's Finalized Guidance on Decentralized Clinical Trials (DCTs): The recent FDA guidance formalizing decentralized elements in clinical trials raises critical questions for Institutional Review Boards (IRBs). While DCTs have existed for years, the official guidance now provides a framework for utilizing healthcare providers (HCPs), remote modalities, and flexible patient engagement. IRBs must consider:Approval Implications: How decentralized elements affect risk-based assessments and informed consent.Data Validity: Whether varying patient experiences impact trial control and data integrity.Protocol Design: Increased complexities in evaluating sponsor protocols that integrate hybrid or decentralized approaches.2. Human Research Protection Programs (HRPPs): IRBs are components of broader HRPPs, which also encompass research compliance, conflict of interest management, and quality auditing. Accreditation bodies like AAHRPP (gold standard for HRPPs) demand higher standards, which could necessitate additional adjustments to align with FDA guidance.3. Regulatory Overlap and Harmonization Challenges: IRBs must navigate overlapping jurisdiction from the FDA and other entities like the Office for Human Research Protections (OHRP). The lack of harmonized regulations between these agencies creates confusion for researchers and inefficiencies in clinical trial oversight.4. FDA Audits and Oversight of IRBs: While the FDA does not directly regulate IRBs, it audits them and issues warning letters or Form 483 observations. IRBs must remain vigilant about FDA compliance, especially with decentralized elements becoming more common.5. Decentralization's Efficiency Debate: There is no blanket conclusion about whether decentralized trials increase efficiency or diversity. IRBs must assess the appropriateness of decentralized approaches on a case-by-case basis, particularly for complex studies like oncology trials or early-phase research requiring hospital stays.6. Calls for Streamlining Oversight: There is growing discussion about reducing redundancy across regulatory bodies to enhance efficiency and lower costs for patients. However, skepticism remains about whether eliminating overlap would ensure adequate protection for trial participants.7. Future Considerations:Adaptation: IRBs must adapt to increased DCT submissions while maintaining rigorous risk-based evaluations.Consistency: Balancing flexibility in decentralized models with the need for consistent oversight practices.Policy Evolution: Ongoing dialogue on whether accrediting bodies like AAHRPP or agencies like OHRP should develop complementary guidance to align with FDA standards.In 2024, IRBs face a critical moment to address these challenges while ensuring that decentralized innovations do not compromise participant safety or trial integrity.Support the show

In this episode, guest host Kate Woods and Darshan Kulkarni delve into current healthcare issues, including the unsettling news of the CEO of United Healthcare being shot. They discuss the broader implications of this event, questioning how it reflects the state of the healthcare system and whether CEOs in troubled companies are becoming targets. The conversation shifts to potential solutions for the healthcare crisis, considering options like Medicare for All and the inefficiencies in drug pricing, where American consumers often subsidize global drug costs. The duo also explores innovation in healthcare, such as adaptive clinical trials, and the role of AI in improving quality and efficiency. They touch on the impact of private equity in healthcare, emphasizing that funding can improve care quality and support staff livelihoods. Overall, the discussion centers on fixing a broken system with a focus on practical changes, accountability, and innovation.Support the show

Welcome to the second episode of Legal Shark Week, a podcast dedicated to exploring the complex and ever-evolving landscape of healthcare law. In this episode, hosts Todd Eury and Darshan Kulkarni introduce the podcast's mission, goals, and what listeners can expect in future episodes. Todd and Darshan discuss the importance of staying informed about legal trends and the critical role that legal expertise plays in the healthcare industry.

Welcome to the inaugural episode of Legal Shark Week, a podcast dedicated to exploring the complex and ever-evolving landscape of healthcare law. In this episode, hosts Todd Eury and Darshan Kulkarni introduce the podcast's mission, goals, and what listeners can expect in future episodes. Todd and Darshan discuss the importance of staying informed about legal trends and the critical role that legal expertise plays in the healthcare industry.  

View the complete show notes for this episode. The Federal Trade Commission (FTC) has issued a new ruling (as of May 2024) regarding the enforceability of non-compete agreements. This ruling will impact every business, regardless of industry, so attorney Darshan Kulkarni joins M&A Talk to discuss the legal and economic implications of this controversial decision. He highlights how employers and attorneys can handle this situation, discusses the potential effects on employees and the legal hurdles still to come, and offers advice for business owners and sellers.  What You'll Learn Enforceability: Insights into the situation since the FTC ruling is facing significant legal challenges and its long-term impact remains uncertain. Usability: Discussion about how non-compete clauses are commonly overused but have valid applications, particularly in M&A transactions, and reasonable restrictions may be enforceable. Legal Counsel: Business owners should promptly address employment agreements with legal counsel to understand compliance obligations and alternative protections. Implications: Thoughts on the future ramifications of this ruling in an overview of the potential legal and economic impact on business owners and employees. Want More? Related Resources:  M&A Non-Compete Agreement | A Complete Guide Alternatives to Non-Competes with Employees “State Noncompete Law Tracker, Economic Innovation Group,” Map showing non-compete laws by state in the United States, June 25, 2024 “Federal Register – Non-Compete Clause Rule,” National Archives document with a summary of the FTC non-compete ruling, May 7, 2024 “Comparative Perspectives on Non-Compete Clauses in the United States, United Kingdom, and Singapore,” Moynihan, Nadia; American Bar Association, September 14, 2023 “FTC Announces Rule Banning Noncompetes,” Federal Trade Commission announcement, April 23, 2024 Additional Resources: Planning to sell your business? Schedule a free consultation today. Download a free PDF copy of The Art of The Exit: The Complete Guide to Selling Your Business, Acquired: The Art of Selling a Business With $10 Million to $100 Million in Revenue, and Food and Beverage M&A: An Insider's Guide to Selling a Food or Beverage Manufacturing, Distribution, or Grocery Business. Purchase your copy now of A Beginner's Guide to Business Valuation | The Exit Strategy Handbook | Closing the Deal Listen to Other Episodes How an M&A Attorney Can Help Sell Your Business with Jessica Fairchild A Lawyer, a Banker, and a Seller Walk Into a Bar … with Michael Frankel Navigating Food and Beverage Regulations for Mergers and Acquisitions with Darshan Kulkarni

In an ideal world, every patient in clinical trials would feel truly represented. In this video, Darshan Kulkarni outlines three crucial takeaways for collecting diversity data in clinical trials, following guidelines from the FDA. The guidance emphasizes that one size does not fit all when it comes to race and ethnicity, encouraging detailed categories to embrace the global diversity of participants. Darshan advises starting by asking about identity, specifically Hispanic and Latino, before delving into race, respecting the complexity of ethnicity and allowing participants to self-identify. He emphasizes the importance of trusting participants to share their own stories, asserting that self-reported data on race and ethnicity is not only more accurate but also honors individual identity, contributing to a more nuanced and enriched dataset.

On "This Week in Pharmacy" Diligent Robotics - Andrea L. Thomaz joins #TWIRx talking about how #Moxie Technology is positively impacting Hospital #Pharmacy. Darshan Kulkarni, with #DarshanTalks updates us on the fight with PBMs and the need for #PBMReform, and Tjasa Zajc, host of Faces Of Digital Health Podcast talks with me about #Pharmacists opportunity and their leverage of #DigitalHealth.

Darshan's LinkedIn: https://www.linkedin.com/in/darshankulkarni/CRIO: http://www.clinicalresearch.ioInato: https://go.inato.com/3VnSro6Join me at my conference! http://www.saveoursites.comText Me: (949) 415-6256My podcast is Random Musings From The Clinical Trials GuruListen on Spotify: https://open.spotify.com/show/7JF6FNvoLnBpfIrLNCcg7aGET THE BOOK! https://www.amazon.com/Comprehensive-Guide-Clinical-Research-Practical/dp/1090349521/ref=sr_1_1?keywords=Dan+Sfera&qid=1691974540&s=audible&sr=1-1-catcorrText "guru" to 855-942-5288 to join VIP list!My blog: http://www.TheClinicalTrialsGuru.comMy CRO and Site Network: http://www.DSCScro.comMy CRA Academy: http://www.TheCRAacademy.comMy CRC Academy: http://www.TheCRCacademy.comLatinos In Clinical Research: http://www.LatinosinClinicalResearch.comThe University Of Clinical Research: https://www.theuniversityofclinicalresearch.com/My TikTok: DanSfera

Guest Part one: Dr. Ashley Dwyer PharmD Dr. Ashley Dwyer is CEO/founder of TeamBDN Coaching and a former pharmacist. After going through a slew of health issues due to lifestyle factors and stress, Ashley saw firsthand just how our current medical system was flawed. This is Ashley's return to the Pharmacy Podcast Network from her first Interview: https://pharmacypodcastnetwork.podbean.com/e/taking-care-of-yourself-first-ashley-dwyer-pharmd/   Guest Part two: Dallas Vasquez is the CEO & Founder of Mitra9, who is introducing Kratom and other botanicals into the mainstream. Darshan Kulkarni, Esq PharmD reports on the Center City Fraud Case. Current and Former Owners of Center City Philadelphia Pharmacy Agree to Pay Over $4.6 Million to Resolve Civil Investigations of Improper Medicare and Medicaid Billing

Darshan Kulkarni emphasizes the importance of selecting the right company for clinical trial recruitment. Key considerations include the company's experience and expertise in a specific disease state or area, its reach (national, international, or local), and the associated costs. He warns against the trend of traditional marketing companies entering the clinical trial recruitment space, advising careful assessment of their experience and disease state knowledge. He also suggests that while this trend is emerging, its ultimate impact remains uncertain. Additionally, he concludes by encouraging those in need of assistance with training, policy development, or gap analyses to contact Darshan Kulkarni at darshan@kulkarnilawfirm.com

In this podcast, five crucial considerations for obtaining approval for a digital speaker program are discussed:1. Privacy Compliance:   - Consider where audience data will be stored and ensure compliance with privacy laws (TCPA, CCPA, GDPR, etc.).   - Prioritize secure handling of sensitive information and always obtain audience consent.2. Transparency and Disclosure:   - Adhere to FTC requirements for transparency and disclosure.   - Communicate upfront about sponsorships, product claims, and any financial relationships impacting the content.3. Controlled Audience Targeting:   - Tailor the digital presentation to specific individuals or groups.   - Adjust tone, scientific detail, and compliance messages based on the target audience (e.g., clinicians, P&T committees).4. Distinguishing Marketing from Education:   - Clearly differentiate between marketing and educational content.   - Ensure that educational materials genuinely inform without serving solely as a sales pitch to benefit from legal protections.5. Product or Health Claim Evaluation:   - Scrutinize the presentation topic to determine if it constitutes a product claim or a disease awareness advertisement.   - Adhere to FDA requirements for product claims, ensuring substantial evidence, while disease awareness ads follow a lower scientific evidence standard.For assistance with digital engagement or marketing programs, contact Darshan Kulkarni at darshan@kulkarnilawfirm.com

Darshan Kulkarni delves into the recently released draft guidance by the Center for Devices and Radiological Health (CDRH) outlining best practices for selecting a predicate device when preparing a 510(k) submission. This guidance underscores four key considerations.The draft guidance emphasizes the significance of technological characteristics. If the new device shares the same technological characteristics as the predicate device, the 510(k) summary should include a comprehensive summary of these features.Design-related recalls take center stage in the FDA's recommendations. The agency discourages choosing a predicate device that has been subject to a design-related recall. If a submitter opts for such a device, they must explicitly address how they've mitigated the safety concerns that led to the recall.Transparency and documentation constitute the third crucial consideration. The FDA stresses the need for a detailed 510(k) summary that provides a comprehensive understanding of the basis for determining substantial equivalence.The guidance encourages the inclusion of a narrative explanation in the 510(k) summary. This narrative should elucidate the process behind selecting the predicate device, offering transparency and insight into the decision-making process.

Darshan Kulkarni discusses the FDA's IT strategy for 2024 to 2027. The FDA aims to create a unified FDA ecosystem, promote cross-functional collaboration, and foster a more integrated organizational culture. Key goals include strengthening IT infrastructure, modernizing enterprise services, and optimizing the IT services portfolio for stable, resilient, and adaptive solutions aligned with mission needs. The FDA emphasizes the importance of sharing data to drive efficiency, excellence, and public health innovation. Additionally, the strategy involves adopting artificial intelligence and staying proactive in identifying opportunities and risks related to emerging technologies.

Darshan Kulkarni talks about how the generic drug industry is facing several challenges that are impacting profitability, including:1. Pressure from insurers to lower prices,2. Rising costs of manufacturing and distribution,3. Inflation,4. Supply chain disruptions and5. Increased competition from other generic companiesPharmacies are fighting back against these challenges by:1. Bypassing wholesalers and negotiating directly with manufacturers,2. Offering discounts and coupons to patients and3. Partnering with other organizations to negotiate lower prices

Planning to incorporate artificial intelligence into your business in 2024? Stay informed about the Federal Trade Commission's (FTC) expectations. In his discussion, Darshan Kulkarni highlights the FTC's recommendations for AI:FTC expects that AI will foster fair, open and competitive markets,FTC intends to use its tools to challenge unfair and deceptive practices involving claims based on AI including the use of AI to discriminate the and FTC intends to promulgate market-wide rules to address harms from AI this includes fake reviews impersonators and other issues.

The FDA's recent decision to cease its enforcement discretion for lab-developed tests (LDTs) has significant implications for developers. To ensure compliance, developers must adhere to a rigorous process. Key steps include:1) Develop a risk-based framework- 0:39- 1:032) Get pre-market clearance or approval- 1:04- 1:373) Quality control and quality assurance- 1:38- 2:044) Adhering to FDA guidelines for labeling and marketing- 2:05- 2:215) Ensuring data security and patient privacy- 2:22- 2:436) Conducting post-market surveillance- 2:44- 3:037) Staying proactive in meeting new compliance requirements- 3:04- 3:20 For expert guidance on FDA approval and regulatory clearance, contact Darshan Kulkarni at 302-252-6959. 

 Darshan Kulkarni emphasizes that companies considering #acquisitions must be ready for scrutiny from multiple agencies: FDA, FTC, DOJ, and OIG. FDA examines various aspects like manufacturing, clinical research, pharmacovigilance, advertising, and distribution. FTC now addresses advertising and antitrust concerns. DOJ concentrates on corporate compliance. Is your organization well-prepared for these assessments? Get in touch with us for more information. 

 Istvan Fekete and Darshan Kulkarni discuss the 7 types of clinical trial agreements (CTAs). CTAs Explored Include:  Industry-Sponsored Trials, Phase Four and Post-Market Studies, Registry Studies, Federally Funded Studies, Drug and Device Studies, Consortium Studies, Investigator-Initiated Studies: We discuss the potential risks of seeding trials, and the need for both sponsors and sites to be vigilant about potential fraud and compliance issues. Discussions include practical advice for both sponsors and sites, encouraging proactive feasibility assessments and streamlined concurrent negotiations. The conversation underscores the multifaceted nature of clinical trial agreements, underscoring their pivotal role in advancing medical research while ensuring ethical practices and efficient collaborations. Join our discussion between Darshan Kulkarni and Istvan Fekete. Receive the latest interview updates directly to your inbox by subscribing to our newsletter at https://darshantalks.com/ #clinicaltrialagreements #researchcontracts #ResearchAgreements #compliancematters #medicalbreakthroughs #trialagreementtips #advancingmedicine #regulatoryguidelines #clinicaltrialethics #darshantalks #dt #kulkarnilawfirm #klf Website: https://www.darshantalks.com/ Law Firm: https://kulkarnilawfirm.com/ Twitter: https://twitter.com/darshantalks

Episode 020: Harsh Thakkar (@harshvthakkar) interviews Darshan Kulkarni (@darshankulkarni), Regulatory and Compliance Attorney at The Kulkarni Law Firm.Darshan talks about the importance of understanding how to use AI properly. He also discusses his work in advertising compliance, which involves ensuring that companies meet the labeling requirements for their products and that their promotional materials are compliant with FDA and FTC regulations. Harsh and Darshan discuss various topics such as the use of AI in education and legal work as well as the challenges and risks associated with using AI-generated content in legal documents and journalism.-----Links:* DarshanTalks* Do you love LS 360 and want to see Harsh's smiling face? Subscribe to our YouTube channel.-----Show Notes:(6:18) AI is not a good writing tool.(8:49) The problem with lawyers and judges using ChatGPT.(14:04) The difference between label and labeling.(18:43) The difference between a drug and a food product.(21:53) Dealing with regulatory inspections and the FDA.(26:56) Responding appropriately to the FDA.(29:47) Dealing with inspections and compliance.For more, check out the podcast website - www.lifesciencespod.com

Darshan's LinkedIn: https://www.linkedin.com/in/darshankulkarni/Veeva Site Vault: https://sites.veeva.com/The University Of Clinical Research: https://www.theuniversityofclinicalresearch.com/Text Me: (949) 415-6256My podcast is Random Musings From The Clinical Trials GuruListen on Spotify: https://open.spotify.com/show/7JF6FNvoLnBpfIrLNCcg7aGET THE BOOK! https://www.amazon.com/dp/1090349521/...Text "guru" to 855-942-5288 to join VIP list!My blog: http://www.TheClinicalTrialsGuru.comMy CRO and Site Network: http://www.DSCScro.comMy CRA Academy: http://www.TheCRAacademy.comMy CRC Academy: http://www.TheCRCacademy.comLatinos In Clinical Research: http://www.LatinosinClinicalResearch.comThe Clinical Research Circle: https://www.youtube.com/channel/UCgOSm8EN_M7xf9Xfw1m778wMy TikTok: DanSfera

This week, Isabel catches up with GOLD's long-time friend Bora Erdemli, Associate Principal and Leader of Medical Affairs Practice, Europe, ZS. She asks Bora to break down the value of the medical affairs function, asking whether it is being properly utilised by pharma organisations. Bora also shares his thoughts on the future of the MSL, what skills new recruits will need to succeed and his top predictions for the next five years in MA. If you're interested in learning more about the topic areas discussed in this episode, check out the following content: Revealing the true value of medical affairs https://www.emg-gold.com/post/revealing-the-true-value-of-medical-affairs Mastering medical affairs https://www.emg-gold.com/post/mastering-medical-affairs Darshan Kulkarni on Super reps, ChatGPT and pharma's future on social media https://www.emg-gold.com/post/podcast-super-reps-chatgpt-and-pharma-s-future-on-social-media

This week, GOLD talks to Darshan Kulkarni, Principal Attorney, The Kulkarni Law Firm, which focuses on regulatory and compliance for life sciences, about key trends in medical affairs and marketing today. He discusses whether MSLs will one day replace sales reps, the role of ChatGPT in healthcare, pharma's future on social media and much more. If you're interested in learning more about the topic areas discussed in this episode, check out the following content: The feature Darshan contributed to: Confronting health inequities for transgender patients https://www.emg-gold.com/post/confronting-health-inequities-for-transgender-patients A takeover, a tweet and trouble for pharma marketers https://www.emg-gold.com/post/a-takeover-a-tweet-trouble-for-pharma-marketers Preparing MSLs for the spotlight https://www.emg-gold.com/post/preparing-msls-for-the-spotlight Davidek Herron on 5 ways pharma can ensure omnichannel success https://www.emg-gold.com/post/5-ways-pharma-can-ensure-omnichannel-success-davidek-herron Mental health matters in pharma's approach to care https://www.emg-gold.com/post/mental-health-matters-in-pharma-s-approach-to-care

The post Artificial Intelligence with Darshan Kulkarni appeared first on Ology of Kelly.

On this episode I was joined by Darshan Kulkarni, Host of DarshanTalks, Attorney at the Kulkarni Law Firm and Adjunct Law Professor at Drexel University. Darshan and I discuss: - Non-Promotional Speech and Scientific Discussion - Medical Affairs vs. Sales and interaction with HCP's - Free Speech in Tech and what it might mean for Pharma Darshan Kulkarni is an FDA regulatory lawyer, author, professor, and speaker, who takes a holistic approach to the healthcare and life sciences industries. Through the lens of patient centricity, including the underlying concepts of privacy, transparency, innovation, and access, Darshan looks at the broader implementation of programs by life sciences companies and healthcare professionals. With a background in creating companies, developing products, and helping guide finished products through the approval process where he has sold products as a pharmacist, Darshan has a unique perspective on how the pharmaceutical, regulatory, and life sciences industries intersect and function.

On this episode, I was joined by Darshan Kulkarni, of - Free Speech and Promotional Compliance - Misbranding - Regulatory vs. Legal Compliance - From Congress to the FDA - the flow from legislation to regulations - Sunshine Act Darshan Kulkarni is an FDA regulatory lawyer, author, professor, and speaker, who takes a holistic approach to the healthcare and life sciences industries. Through the lens of patient centricity, including the underlying concepts of privacy, transparency, innovation, and access, Darshan looks at the broader implementation of programs by life sciences companies and healthcare professionals. With a background in creating companies, developing products, and helping guide finished products through the approval process where he has sold products as a pharmacist, Darshan has a unique perspective on how the pharmaceutical, regulatory, and life sciences industries intersect and function.

Welcome to another episode of I Am Christina DiArcangelo!  Today, Darshan Kulkarni, Pharm.D, MS, Esq. of the Kulkarni Law Firm joins me to discuss his career in law, pharmacy, and teaching.  Currently teaching at Drexel Law with a focus on FDA regulatory law and commercial compliance, he is also a published author and podcast host supporting both topics.  With an extensive career and passion for being a world traveler, he shares why he continues to be a student and why this has become his life's work.Darshan Kulkarni, Pharm.D, MS, Esq.The Kulkarni Law FirmTwitter: @DarshantalksYoutube Channel: https://www.youtube.com/c/DarshanTalksChristina DiArcangeloAffinity Bio Partners, LLCSpectral AnalyticsSpectral Analytics Precision Tele-MonitoringI Am Christina DiArcangelo

Darshan Kulkarni, PharmD JD, is excited to welcome guest Jay Holloway, Pharm D. to discuss Rules about Trans Representation in the #pharmacy on this episode of the DarshanTalks Podcast.  They discuss #healthequity , his experiences working as an illustrator, addressing trans populations, terms like #genderdiversity, the weight of the term #masculine and what #masculinity means, #cisgender#sexualorientation #genderidentity, and how it connects to #LGBTQ+ populations. They also discuss what it takes to manage a trans identity, insurance and reimbursement coverage, job discrimination, the role of #Rxshare and more.  Learn more about your ad choices. Visit megaphone.fm/adchoices

Darshan Kulkarni, PharmD JD, is excited to welcome guest Jay Holloway, Pharm D. to discuss Rules about Trans Representation in the #pharmacy on this episode of the DarshanTalks Podcast.  They discuss #healthequity , his experiences working as an illustrator, addressing trans populations, terms like #genderdiversity, the weight of the term #masculine and what #masculinity means, #cisgender#sexualorientation #genderidentity, and how it connects to #LGBTQ+ populations. They also discuss what it takes to manage a trans identity, insurance and reimbursement coverage, job discrimination, the role of #Rxshare and more.  Learn more about your ad choices. Visit megaphone.fm/adchoices

Who owns the clinical trial data generated in industry sponsored or investigator initiated clinical trials? What responsibilities do Sponsors, CROs, or Sites have when it comes to sharing clinical trial results with patients? Should a Sponsor get access to patient data collected outside a clinical trial setting? To answer these questions and more, I invited Darshan Kulkarni to the show. Darshan is a regulatory attorney specializing in FDA law, professor, author, and speaker. He is currently the Principal Attorney of Kulkarni Law Firm where he focuses his practice on providing healthcare companies with legal, compliance, and regulatory advice. He has led rare disease pharmaceutical companies in developing global programs to foster clinical trial transparency and enhance public health. He serves on the editorial board for Applied Clinical Trials at Advanstar Communications serving as a legal advisor on the clinical trial industry.  Previously, Darshan was on the editorial board of cosmetics and personal products for FDAnews where guided the publication with his clinical trial and pharmaceutical expertise. Last but not the least he is the host of the DarshanTalks livestream interviews where he discusses issues that impact the life science industry. This podcast is brought to you by Florence Healthcare. The learn more, please visit florencehc.com  

4 Can't Miss Trends about Digital Engagement! Coming up on Friday's livestream of the DarshanTalks Podcast with host Darshan Kulkarni and guest Ritesh Patel, originally streamed on July 15th, 2022.  Learn more about your ad choices. Visit megaphone.fm/adchoices

4 Can't Miss Trends about Digital Engagement! Coming up on Friday's livestream of the DarshanTalks Podcast with host Darshan Kulkarni and guest Ritesh Patel, originally streamed on July 15th, 2022.  Learn more about your ad choices. Visit megaphone.fm/adchoices

I recently had a truly unique opportunity to discuss a complex yet rapidly evolving topic of how to use and update our social media and digital communication policies with social and healthcare responsibility while improving our impact on the quality and timeliness of medical decisions! Darshan Kulkarni, PharmD, MS, Esq is a dynamic expert educator in this field who owns his private law firm, is a life sciences counselor, speaker, author, board member, and host of the DarshanTalks podcast who shared his perspectives on the latest developments in this field. Below are the highlights from our discussion. 6:20 Pharma and device social media / digital communication policies are highly variable across small and mature companies. Some smaller teams are building them from scratch, yet others are not updating them either deliberately, not prioritizing them, or are not addressing off-label discussions and their impact. 7:52 There have been several court cases that have admonished the FDA for being overly aggressive with its enforcement. The FDA released a 60-page memo in which it acknowledged that it does not know what to do with off-label discussions in social media or via multiple digital channels.8:30 In 1998 there were 195 or so warning letters from the FDA's DDMAC division and last year there were only 6. The FDA is trying to get its bearings on what is happening. Many companies have not updated their HCP engagement policies. The Pharma organization updated its policy in mid-January. There are discussions around "space limited" engagements. On social media, you have to decide whether or not your will have social media pages that are product based, company based, or claims-based. 11:44 What are any differences in risk and liability of a Medical vs Sales organization in pharma today? The DOJ had several court cases in the early 2000s that said either you have a Medical Affairs department that is absolutely separate or you both abide by commercial speech standards, not Amendment 1. For decades, the FDA regulated based on approvals, so if the requirement based on the standard of "truthful not misleading" is thrown out it may upend the entire regulatory schema that existed. So the court responded that the 1st amendment has been changing since the 1980's but the FDA has not updated it. 16:03 The FDA is convening a Task Force to address 1st Amendment application concern in pharma. 17:22 Most pharma companies are still operating under a clear distinction between Medical and Sales from early 2000s but this will likely change in the next 2-5 years. 17:40 Q: What are some types of social media activities that are safe vs others that are more scrutinized? 21:48 CDRH in Medical Devices has significantly less resources than CDR's OPDP in pharma, and this is why the regulations in medical devices are much more loosely defined. 25:05 Has the line of "misleading" changed over the last few years? How can we balance the misleading medical information used by patients themselves? 27:05 Confident and Reliable Scientific Evidence (CRS) FDAMA114 - lowest level of truthful not misleading information. The second is Substantial Scientific Evidence (SSE) which is rarely if ever used. The third level of information used for claims is Substantial Evidence, classically referred to as two randomized controlled studies (RCTs) needed for drug approval. The New Patient Focused Drug Development FDA guidance is now advocating for pharma to communicate with patients. EMA has lay summaries to communicate clinical trial results in a language accessible to the general public. Many ICMJE journals now require for trial sponsors to provide a lay summary for patients prior to consideration of publication. 41:20 How are the current latest regulations impacting how transparent we can or have to be in reporting clinical trials? There are 7 levels of clinical trial transparency (discussed in detail).

Tune into the Darshan Talks Podcast as we discuss pharmacy law. The host Darshan Kulkarni invites guest Erin Albert to share her insights, views, experiences, and much more. Erin Albert PharmD JD MBA CPBS CHVP - Edutainer, is a Kinetiq Health Pharmacy Benefit Practice Leader at Apex Benefits, Co-Host of The Point Podcast, President of American Society for Pharmacy Law. The conversation began with the question of what is pharmacy law on which the expert explained that it is a curious intersection of pharmacists and regulatory aspects. While pharmacy is already a highly regulated industry, it offers various niches for lawyers who are now pharmacists. For example, one person might know the life sciences and regulatory aspect but completely not expertise in reimbursement. It is the broader intersection of law and the pharmacy profession. Erin leads ASPL. ASPL is a combination of lawyers, pharmacists, and pharmacists-lawyers who like to talk about pharmacy, law, ethics, and policy that directly relate to healthcare. They are in total five hundred members associated with ASPL, an annual conference is held every year, two and half days of legal and pharmacy education. ASPL helps develop leadership, education and brings thought leaders in the space of pharmacy and law to work on a year-long project ---- Disclaimers: 1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact. 2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated, or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization. 3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product. 4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice, or medical advice. 5. This does not create an attorney-client relationship. Learn more about your ad choices. Visit megaphone.fm/adchoices

Tune into the Darshan Talks Podcast as we discuss pharmacy law. The host Darshan Kulkarni invites guest Erin Albert to share her insights, views, experiences, and much more. Erin Albert PharmD JD MBA CPBS CHVP - Edutainer, is a Kinetiq Health Pharmacy Benefit Practice Leader at Apex Benefits, Co-Host of The Point Podcast, President of American Society for Pharmacy Law. The conversation began with the question of what is pharmacy law on which the expert explained that it is a curious intersection of pharmacists and regulatory aspects. While pharmacy is already a highly regulated industry, it offers various niches for lawyers who are now pharmacists. For example, one person might know the life sciences and regulatory aspect but completely not expertise in reimbursement. It is the broader intersection of law and the pharmacy profession. Erin leads ASPL. ASPL is a combination of lawyers, pharmacists, and pharmacists-lawyers who like to talk about pharmacy, law, ethics, and policy that directly relate to healthcare. They are in total five hundred members associated with ASPL, an annual conference is held every year, two and half days of legal and pharmacy education. ASPL helps develop leadership, education and brings thought leaders in the space of pharmacy and law to work on a year-long project ---- Disclaimers: 1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact. 2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated, or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization. 3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product. 4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice, or medical advice. 5. This does not create an attorney-client relationship. Learn more about your ad choices. Visit megaphone.fm/adchoices

Tune in to this episode, Law Changes and Updates: What Pharma Marketers Need to Know, with our friend and Editorial Advisory Board member and returning guest,  Darshan Kulkarni, Attorney of Law at the Kulkarni Law Firm which advises life science companies and their advisors including marketing and PR agencies with compliance issues, promotional review, audits and training. He is also a Pharmacist, Book Author and Professor, and host of the world famous Darshantalks podcast which focuses on emerging life science issues. He is joined by the incomparable Jennifer Ginest, Digital Marketing Manager at the Pharma Marketing Network. Find out what law and regulation changes could impact your brand now and in the future.

We talk a lot about compliance usually its compliance within the pharmacy. Today I have Darshan Kulkarni from the Kulkarni law firm talking about compliance with your sales team. Since there's so much information to impart this topic is broken into two sections during the first one Darshan will discuss some of the key regulations regarding fair market value, the False Claims Act and the anti kickback law. Part Two, will cover examples of pharmacies that are under investigation, why the fines and penalties associated with their transgressions and how marketers can get sued for their involvement. If you'd like to see the PowerPoint slides that accompany this information, you can watch the video on our YouTube channel. You can find it by typing in our name PharmaSalon If you have any questions for Darshan he can be contacted at 302-252-6959 or on Twitter @Darshan talks. If you like this podcast, don't forget to subscribe or leave a comment. You can do so on Twitter, Facebook or  our LinkedIn page. You can also leave us a voicemail on our website.You can watch this presentation with the PPT on our youtube channel. Click hereSupport the show (https://www.buymeacoffee.com/pharmasalon)

The Pharma Marketing Podcast is pleased to present this special guest episode from our friend and Editorial Advisory Board member Darshan Kulkarni, Marketing and Evolving Patient Centricity – January 27, 2021. The discussion between host, Darshan Kulkarni, Head of Growth at Gentem Health, Omar Khateeb, and Director of DTC & HCP Marketing at Bausch Health, Keith Peiper discusses the importance of tracking patients and their journeys, educating patients, and building patient trust. Check out DarshanTalks for more of his insightful podcasts.

Title: Darshan Kulkarni on Amazon Pharmacy In 2017, Darshan Kulkarni PharmD, MS, Esq., predicted that Amazon would soon disrupt the pharmaceutical industry on the Gavel & Pestle Podcast. Three years later, his eerily accurate predictions are unfolding before us. On this special episode of Gavel & Pestle, the FDA regulatory lawyer, author, professor, and speaker returns to pass the baton to the podcast's new host Brooke Kulusich. They discuss Amazon Pharmacy's potential to singlehandedly reshape the pharmaceutical supply chain, its implications for patient health data and drug prices, and the future of pharmacy from drone delivery to Alexa pharmacists.  Listen to Darshan's predictions here.  Follow Gavel & Pestle on Twitter here.  Contact us today for a Gavel & Pestle Podcast appearance at publisher@pharmacypodcast.com. See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Title: Darshan Kulkarni on Amazon Pharmacy In 2017, Darshan Kulkarni PharmD, MS, Esq., predicted that Amazon would soon disrupt the pharmaceutical industry on the Gavel & Pestle Podcast. Three years later, his eerily accurate predictions are unfolding before us. On this special episode of Gavel & Pestle, the FDA regulatory lawyer, author, professor, and speaker returns to pass the baton to the podcast's new host Brooke Kulusich. They discuss Amazon Pharmacy's potential to singlehandedly reshape the pharmaceutical supply chain, its implications for patient health data and drug prices, and the future of pharmacy from drone delivery to Alexa pharmacists.  Listen to Darshan's predictions here.  Follow Gavel & Pestle on Twitter here.  Contact us today for a Gavel & Pestle Podcast appearance at publisher@pharmacypodcast.com. See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Darshan is the Principal Attorney of the Kulkarni Law Firm, and focuses his practice on providing life science, healthcare and healthtech companies with comprehensive regulatory advice. Darshan has worked at multiple Venture Capital backed in-house positions, and started multiple legal departments including at Embedded Healthcare, LLC where he served as General Counsel and Chief Compliance Officer and as Corporate Counsel for Nostrum Pharmaceuticals where he was responsible for and oversaw multiple legal and compliance matters including issues relating to advertising, clinical research, and creating and reviewing a variety of agreements including NDAs, MSAs, CDAs, employment agreements, and licensing agreements. He has created multiple compliance programs including addressing issues relating to the False Claims Act, Anti-Kickback Law, HIPAA, HITRUST issues etc. Most recently, he has also served as Vice President of Regulatory Strategy and Policy at Synchrogenix, another Venture Capital backed global consulting company. He has spent over 20 years counseling clients on regulatory issues, and has served as a pharmacist for over a decade.Darshan has also written several book chapters on regulatory compliance for various publications on behalf of the American Bar Association where he is Chair of the Life Sciences Interest Group. In this episode, we discuss parsing the biotech enigma. Why is there a boom in biotech right now? What is patient centricity and does it matter in the biosciences? Is transparency the cure to the lack of trust in the biosciences? What is biohacking and is it the future of bioscience?

Quick podcast from Darshan Kulkarni, PharmD, Esq., about hiring the right 5 people to help you build a successful compounding business.  This episode is sponsored by AudioRx.study.  See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

The Pharma Marketing Podcast is pleased to present this special guest episode from our friend and Editorial Advisory Board member Darshan Kulkarni, Insys & Mallinkrodt: Is legal really necessary on your promotional review teams? from his podcast series, Darshan Talks.

Gavel & Pestle Podcast host Darshan KulKarni talks with Emmanuel Fombu, MD, MBA (Manny) the author of the best selling book titled, The Future of Healthcare: Humans and Machines Partnering for Better Outcomes Emmanuel Fombu, MD, MBA, is a physician, author, speaker and healthcare executive turned Silicon Valley entrepreneur. As a medical futurist and 2017 winner of the prestigious New York City Health Business Leaders Boldest Digital Health Influencer Award, Dr. Fombu champions the potential for the internet of things, artificial intelligence and machine learning to revolutionize the healthcare industry. https://www.emmanuelfombu.com/  See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Telepharmacy is the delivery of pharmaceutical care via telecommunications to patients in locations where they may not have direct contact with a pharmacist. It is an instance of the wider phenomenon of telemedicine, as implemented in the field of pharmacy. Darshan Kulkarni, host of the Gavel & Pestle Podcast and VP Regulatory Strategy & Policy with Synchrogenix interviews Timothy Youkhana President with Scaled Enterprise Solutions about telepharmacy opportunities for pharmacy business.  Telepharmacy services include drug therapy monitoring, patient counseling, prior authorization and refill authorization for prescription drugs, and monitoring of formulary compliance with the aid of teleconferencing or videoconferencing. Remote dispensing of medications by automated packaging and labeling systems can also be thought of as an instance of telepharmacy. Telepharmacy services can be delivered at retail pharmacy sites or through hospitals, nursing homes, or other medical care facilities. The term can also refer to the use of videoconferencing in pharmacy for other purposes, such as providing education, training, and management services to pharmacists and pharmacy staff remotely. ABOUT --Scaled Enterprise Solutions https://ses.healthcare/about/  See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Gavel & Pestle Podcast host Darshan Kulkarni, PharmD, JD talks about the importance of understanding regulations on marketing and advertising anything about medical marijuana.  Advertisements are not Exempt  Don't Wing It  FDA Ads  Disease Awareness Product Awareness  Product Claims Advertisement  FDA Listing of Advertising Guidances https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064956.htm FDA and Marijuana: Questions and Answers https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421168.htm     See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices