Podcasts about Rx

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

CC416: Lindsie and Kail discuss trying to find a new way to explain what they do for work that doesn't insinuate sketchy internet activities. Today's news topics are all sorts of wild; a young dad doesn't want to change his daughter's diaper, a fiancé wants to honor her husband who passed away by wearing their ring around her neck at the new wedding, and some inmates escape a prison in New Orleans that sounds straight from the books. Today's Foul Play is an unfortunate one that many mom might relate to!Thank you to our sponsors!Buffy: Get 20% off your first Buffy order using code COFFEE at Buffy.coFrankie4 Shoes: Head to US.FRANKIE4.COM and use code COFFEE for 20% off full-price styles. Valid until the end of June.RoBody: Find out if you're covered for free at Ro.Co/COFFEECONVOS. Rx only.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Timestamps: 0:00 it's been a day 0:14 RX 9060 XT, RTX 5060 2:03 Intel Arc Pro B60 24GB 2:57 Google I/O - Veo 3 video model 4:10 Google's "available now" stuff 5:47 Google's "not available yet" stuff 6:39 UPDF ! 7:28 QUICK BITS INTRO 7:35 Microsoft Build 2025 8:22 Fortnite back on US App Store 9:10 Huawei Matebook Fold 9:35 Noctua x Pulsar mouse with fan NEWS SOURCES: https://lmg.gg/CkpBB Learn more about your ad choices. Visit megaphone.fm/adchoices

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

While few doubt the opportunity represented by real-world evidence, some concerns remain about its validity compared to traditional forms of clinical evidence, particularly among regulators. To address these concerns, IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer, suggests that incorporating some elements of traditional trials, such as randomization, is a good way to persuade regulators that RWE can be used for consumer health innovation, for example in generating new claims or supporting Rx-to-OTC switch. Looking forward, Spitzer is excited about the ways in which digital health tools and artificial intelligence can be used to expand the scope of RWE as well as drive personalization for consumers. Timestamps: 3:00 - Addressing concerns about RWE's scientific rigour and validity 12:00 – Regulators' views of RWE, particularly for consumer health 16:00 – Use of RWE for Rx-to-OTC switch 22:00 – The future of RWE Guest Bio: Volker Spitzer has more than 30 years of R&D experience spanning the consumer health sector, ingredients industry, and academia. Beginning his career as a professor in pharmaceutical sciences, he ascended to global positions encompassing R&D, innovation, licensing/M&A, and medical marketing at firms like Roche, DSM Nutritional Products, and Bayer. Since October 2017, Spitzer has been affiliated with IQVIA Consumer Health, serving as the vice president for global R&D and RWE Services. His purview primarily includes clinical research, RWE, virtual trials, and the burgeoning field of digital health. He has penned over 80 scientific publications, whitepapers and textbooks centered on science and innovation.

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

CC415: On this month's bonus episode... Lindsie and Kail are in New York City getting ready for a day of recording. Or that was the plan at least... Lindsie and Kristen continue where the chaos was left off.Thank you to our sponsors!Chime: Get started at chime.com/convosDraftKings: Download the DraftKings Casino app and sign up with promo code COFFEEIQBar: Get 20% off every IQBar product plus free shipping when you text CONVOS to 64-000. By Texting 64000, you agree to receive recurring automated marketing messages from IQBAR. Message and data rates may apply. No purchase required. Terms apply, available at IQBAR.com. Reply "STOP" to stop, "HELP" for helpProgressive: Visit Progressive.com to learn moreRoBody: Find out if you're covered for free at Ro.Co/COFFEECONVOS. Rx only.Stamps: Visit Stamps.com and use code COFFEE for a 4-week trial, free postage, and a digital scale!See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Dr. Chirag Shah, co-author of Financial Freedom of Rx with Jay, joins the program to discuss personal finance in the context of current market conditions and best practices as trainees near graduation.

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

Timestamps: 0:00 See ya on Wed, May 21 0:09 Epic's plan for Apple to block Fortnite 3:29 Intel Arc Pro B60, RX 9060 XT 4:27 OpenAI Codex, Grok's breakdown 5:50 MSI! 6:41 QUICK BITS INTRO 6:47 Spotify podcast play counts 7:14 The Steam data breach that wasn't 7:41 Australian rocket top fell off 8:07 BREAKING: Vader is bad guy NEWS SOURCES: https://lmg.gg/oRJxT Learn more about your ad choices. Visit megaphone.fm/adchoices

We were off last week, and somehow we STILL haven't reached Computex. So, another pre-show show, full of speculation (and speculative exploits).   With no time to spare, we talk about Epyc, RX 9060 and RX 9070's, ceramic storage and Windows 3.1 - but not in that order.Timestamps: 00:00 Intro 00:56 Patreon 01:55 Food with Josh 03:58 Radeon RX 9060 XT clocks and pricing 05:54 RX 9070 GRE is a product that exists 07:14 WD_Black SN8100 is reaching for the Gen5 crown 09:59 AMD goes GRADO 18:19 Asetek patent expires - AiO competition will be fierce 20:22 Win 3.1 icons are hiding inside your Windows install RIGHT NOW 25:43 Microsoft fixes boot issues with Linux/Windows dual-boot systems 27:43 Podcast sponsor NordLayer 29:14 (in)Security Corner 44:08 Gaming Quick Hits 53:59 Jeremy has gone MAD (for ARGB) 1:03:28 Picks of the Week 1:17:59 Outro ★ Support this podcast on Patreon ★

This the ideal episode for any active people looking for more reasons to get outside and get moving! The guest, Julia Hotz, is a journalist, marathon runner, and the author of The Connection Cure: The Prescriptive Power of Movement, Nature, Art, Service, and Belonging. Along with hosts Sarah Bowen Shea and Amanda Loudin, she details: -the mood-boosting effects of being active in nature;  -the health benefits of hobbies;  -the importance of doing what matters to you;  -an argument for not multi-tasking; and,  -an Rx for a best running friend.    Before the guest joins around 10:54, the hosts swap stories about their recent open-water swimming exploits, including Amanda's in a 57-degree (13 Celsius) pond in London!   When you shop our sponsors, you help AMR.We appreciate your—and their—support!   A bright idea: Get 20% off Tifosi sunglasses with code AMR2025 at TifosiOptics.com   Portland's the place! Use code AMR20 for $20 off registration at portlandmarathon.com   Sleep soundly: Save 25% off at CBDistillery.com with code AMR Learn more about your ad choices. Visit megaphone.fm/adchoices

Episode 71: We chat about potential upcoming Intel Arc GPUs including the B770 and B580 24GB, discuss the RX 9060 XT and what AMD might do with pricing, and round out the chat with some discoveries about laptop GPUs.CHAPTERS00:00 - Intro05:13 - Intel Arc B770, Is It Real?22:10 - New Arc B580 Configurations?26:18 - Lead-Up to the RX 9060 XT39:04 - Price Considerations and Concerns with 9060 XT1:04:30 - The RTX 5090 Laptop is a Joke1:14:25 - Updates From Our Boring LivesSUBSCRIBE TO THE PODCASTAudio: https://shows.acast.com/the-hardware-unboxed-podcastVideo: https://www.youtube.com/channel/UCqT8Vb3jweH6_tj2SarErfwSUPPORT US DIRECTLYPatreon: https://www.patreon.com/hardwareunboxedLINKSYouTube: https://www.youtube.com/@Hardwareunboxed/Twitter: https://twitter.com/HardwareUnboxedBluesky: https://bsky.app/profile/hardwareunboxed.bsky.social Hosted on Acast. See acast.com/privacy for more information.

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

In part 2 of a critical two-part series, Etienne Nichols and regulatory affairs expert Mike Drues explore the nuanced pathway of switching a medical device from prescription (Rx) to over-the-counter (OTC). This episode dives deep into what triggers a new submission, how usability testing and human factors play an expanded role for lay users, and the regulatory logic that guides these transitions. The conversation highlights the importance of aligning regulatory strategy with business goals, and offers practical insights on leveraging real-world evidence, understanding the limits of FDA databases, and optimizing pre-submission meetings.Key Timestamps02:10 – Starting from a cleared 510(k): Do you need a new submission for OTC?06:45 – Implications of removing the healthcare provider from the equation12:00 – Risk management: Expanding risk profiles when lay users are involved18:15 – When a 510(k) becomes a De Novo or PMA22:50 – Usability testing and the risk of user error in OTC devices31:20 – Clinical investigations and good clinical practices (GCPs)36:00 – Real-world evidence vs. real-world data—what's usable?41:30 – Using Pre-Subs effectively and what “quality data” really means47:10 – Labeling, cleaning, and UDI for OTC products53:40 – OTC software and digital health—when is it a regulated device?01:00:00 – Summary: Aligning regulatory logic with common sense and business strategyQuotes“With an OTC device, we are taking the healthcare professional totally, completely, and utterly out of the loop.”– Mike DruesThis quote encapsulates the core regulatory challenge in moving a device to OTC: every element, from labeling to usability, must assume zero clinical supervision.“If the clinical trial won't tell you anything you don't already know from good real-world evidence, why spend the time and money?”– Mike DruesA powerful argument for using well-documented real-world evidence over unnecessary trials—provided the data truly meets evidentiary standards.Top TakeawaysLabel Expansion ≠ Shortcut: Moving from prescription to OTC usually requires a new submission—especially when removing the healthcare provider introduces new risks.Usability Testing Is Critical: OTC usability studies must go beyond IFU comprehension to include risk of misuse, poor device selection, and user decision-making.Real-World Evidence Can Help—If It's Clean: Real-world data isn't always usable. FDA will expect reproducibility, traceability, and strong justifications.Labeling & Design Must Assume No Clinical Oversight: Cleaning procedures, warnings, and directions must all be validated for home use and layperson comprehension.Use Pre-Subs Wisely: Especially for label expansions or gray-area digital health tools, pre-subs provide critical alignment with FDA and prevent costly errors.References & ResourcesEtienne Nichols on LinkedInFDA Guidance on Real-World Evidence for Regulatory Decision-MakingGreenlight Guru Webinar: What is and Isn't a Regulated Medical Device (feat. Mike Drues)FDA Guidance: Clinical Decision Support SoftwareMedTech 101: OTC vs Prescription DevicesAnalogy: Think of prescription vs. OTC devices like driving a manual vs. automatic car. Prescription devices assume a trained “driver” (the healthcare provider), while OTC devices must be intuitive and safe enough for anyone to “drive”...

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

Prepare your beam sabers and polish your Zaku helmets-this episode of Play Comics is about to launch straight into the Universal Century! We're diving headfirst into the PS2 classic Mobile Suit Gundam: Federation vs Zeon, where the only thing more intense than the space battles is trying to pronounce “RX-78-2” three times fast. Joining the fray is none other than Derek Van Dyke from Super Deluxe GamesCast and Castle Bravo, who's here to help us decide once and for all: Is it better to fight for the Federation, or is life just more fun in a mono-eyed mobile suit? Expect hot takes, cooler mobile suits, and at least one attempt to dodge a colony drop with nothing but sheer podcasting bravado. So grab your joystick, pick a side, and get ready for a barrage of wit, wisdom, and way too many references to Newtypes. The One Year War has never sounded this entertaining. Learn such things as: How real is the science of Gundam? Do you really have to play as one of the characters to have a game that feels right? If I thought of a story arc that already existed, does that make me a genius or just guilty of pre-plagarism? And so much more! You can find Derek on BlueSky and of course as part of the Super Deluxe GamesCast and Castle Bravo. If you want to be a guest on the show please check out the Be a A Guest on the Show page and let me know what you're interested in. If you want to help support the show check out the Play Comics Patreon page or head over to the Support page if you want to go another route. You can also check out the Play Comics Merch Store. Play Comics is part of the Gonna Geek Network, which is a wonderful collection of geeky podcasts. Be sure to check out the other shows on Gonna Geek if you need more of a nerd fix. You can find Play Comics @playcomics.bsky.social on Bluesky, @playcomicscaston Twitter and in the Play Comics Podcast Fan Groupon Facebook. A big thanks to the Kickstarter campaign for I Brought A Gorilla to a Gunfight and The Monitor Tapes for the promos today. Intro/Outro Music by Backing Track, who really wants you to know that no real life children were made to do war crimes in the making of this podcast episode. Support Play Comics by contributing to their tip jar: https://tips.pinecast.com/jar/playcomicsRead transcript

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

CC413: Let's dive into the chaos! Kail and Lindsie are period buddies this month and have the worst case of bloating ever. To strategizing their Webby Award outfits, debating Rolexes, and sharing unsolicited driving school expertise. plus listener questions! Listeners ask for advice on navigating a serious situation regarding a school bathroom policies gone wrong, another asks about the loneliness of post-divorce living, and someone writes in about their father being in prison with Scott Peterson! Disturbing news of drug runners using candy-colored trash cans at playgrounds has everyone highly concerned. And speaking of concerned, Lindsie and Kail express curiosity in wanting to spend time with inmates at their local prison... Buckle up, Kitty cats!Thank you to our sponsor!Better Help: This episode is brought to you by BetterHelp. Visit BetterHelp.com/coffee today to get 10% off your first monthHoney Love: Start spring off right with Honeylove. Get 20% OFF by going to honeylove.com/Coffee!IQBar: Get 20% off every IQBar product plus free shipping when you text CONVOS to 64-000. By Texting 64000, you agree to receive recurring automated marketing messages from IQBAR. Message and data rates may apply. No purchase required. Terms apply, available at IQBAR.com. Reply "STOP" to stop, "HELP" for helpRoBody: Find out if you're covered for free at Ro.Co/COFFEECONVOS. Rx only.Rocket Money: Manage your expenses the easy way by going to RocketMoney.com/COFFEECONVOSSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Timestamps: 0:00 pow pow! for king and country 0:06 Xbox 'Project Kennan' handheld leak 1:48 12-inch Surface Pro, 13-inch Surface Laptop 3:00 University AI crisis 4:21 Odoo! 5:22 QUICK BITS INTRO 5:32 RTX 5060, RX 9060 XT coming 6:07 Core Ultra 7 265K price cut, Core 2 Duo 6:42 Nvidia, Mediatek Arm PC chip 7:02 π0.5 powers household robots 7:34 Electrically-conducting bacteria NEWS SOURCES: https://lmg.gg/mOigB Learn more about your ad choices. Visit megaphone.fm/adchoices

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

Continuing a recap of the 2025 Rx and Illicit Drug Summit, KET interviews Kentucky Attorney General Russell Coleman; Van Ingram, executive director of the Kentucky Office of Drug Control Policy; and Tom Vicini, president and CEO of Operation UNITE. Recovery, treatment and prevention groups featured on the program include Lifeline Recovery Center in Paducah and Scott County Detention Center.

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

In Part 1 of this two-part series, Etienne Nichols sits down with regulatory strategist Dr. Mike Drues to explore the nuanced differences between prescription (Rx) and over-the-counter (OTC) medical devices. They demystify key terms, regulatory classifications, and the growing trend of label expansions from Rx to OTC—highlighting real-world examples like CPAP machines and continuous glucose monitors (CGMs). This episode unpacks how intended users, environments, and risk tolerances shape device categorization, and why usability testing is far more complex than many realize. Whether you're developing a consumer health product or preparing a label expansion strategy, this is a must-listen for your regulatory roadmap.Key Timestamps[03:05] – What defines an OTC vs. prescription medical device?[06:45] – Market size of OTC devices and major product categories10:00 – Label expansion: moving from Rx to OTC status13:22 – The role of intended use environment in OTC classifications20:40 – Examples of devices in each FDA class that are OTC26:30 – Prescription devices used in home settings vs. true OTC31:15 – Characteristics that qualify devices for OTC status37:55 – Self-diagnosis, self-selection, and patient usability challenges43:00 – “Reasonably foreseeable misuse” and how to interpret guidance49:05 – Do you design for the lowest common denominator?56:10 – Representing diverse user populations in usability testing1:01:45 – Can a device launch OTC first? The case for wellness-to-Rx strategies1:08:15 – FDA's perspective on device safety: OTC vs. RxQuotes“The best regulatory professionals don't just know the rules—they know the exceptions.”Dr. Mike Drues reminds us that exceptional regulatory strategy lies in understanding nuance, especially in OTC classifications where edge cases can redefine categories.“Just because a device is used at home doesn't mean it's over the counter.”This insight challenges a common industry assumption, underscoring the importance of carefully defining intended use and environment early in development.Key TakeawaysOTC ≠ Low Risk by Default – Many Class II and even rare Class III devices can be OTC; it's more about intended user, use environment, and risk mitigation than class alone.Label Expansion Requires Strategy – Transitioning a device from prescription to OTC isn't just about removing a doctor's role—it may involve new usability studies, labeling changes, and potentially a 510(k) or de novo submission.Understand the "Intended Use Environment" – FDA doesn't just care about where the device is used, but how those environmental parameters (like light, humidity, and user training) affect safe operation.Usability Testing Must Reflect Real Users – For OTC devices, human factors validation must account for diverse educational backgrounds, not just ideal users.Don't Rely on Labels Alone – Whether or not users read (or understand) instructions must be tested, not assumed. Intuitive design is critical for OTC success.References & ResourcesEtienne Nichols on LinkedInGreenlight Guru Medical Device Classification Webinar with Mike Drues (for explanation on device classes)FDA Guidance: “Factors to Consider When Making Benefit-Risk Determinations in Medical Device...

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

"Metaphors are essential in plugin design!" Bill talked about Native Instruments, managing new products at iZotope, the importance of good speakers in the studio, how AI will help your sonic perspective, and using Ozone, RX, and the Catalyst plugins. Get access to FREE mixing mini-course: https://MixMasterBundle.com My guest today is Bill Podolak, a Senior Product Manager at iZotope by Native Instruments. Bill has had the privilege of managing the past two versions of Ozone 10 and 11 along with RX 11 and their new Catalyst Series - Plasma, Aurora, and Cascadia. He is also a musician and music producer and makes tracks in his spare time. His wife is also a singer-songwriter, and they make music together. Thank you to Dave Godowsky for the introduction! THANKS TO OUR SPONSORS! http://UltimateMixingMasterclass.com https://usa.sae.edu/ https://www.izotope.com Use code ROCK10 to get 10% off! https://www.native-instruments.com Use code ROCK10 to get 10% off! https://www.adam-audio.com/ https://stealthchair.com/ Use code ROCK10 to get 10% off! https://www.makebelievestudio.com/mbsi Get your MBSI plugin here! https://RecordingStudioRockstars.com/Academy  https://www.thetoyboxstudio.com/ Listen to the podcast theme song “Skadoosh!” https://solo.to/lijshawmusic Listen to this guest's discography on Spotify: https://open.spotify.com/playlist/4zUBC1bygkBypno6yiYcEU?si=3f4deed105b94924 If you love the podcast, then please leave a review: https://RSRockstars.com/Review CLICK HERE FOR COMPLETE SHOW NOTES AT: https://RSRockstars.com/504

Shocking court docs reveal a twisted motive for murder: Prosecutors say an accused murderer's secret gender identity battle, and jealousy over the victim's beauty, drove them to kill. A woman's terrifying screams capture a killer's brutal act. That 37-second voicemail led to a guilty verdict. Plus, a driver's RX-cuse for not paying attention on the road! Jennifer Gould reports.See omnystudio.com/listener for privacy information.

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

Presented by City Club of Portland, with support from AARP Oregon, Fight Against Sex Trafficking, Neil Kelly, and City Cast Portland.City Club is a member-led and member-supported 501(c)(3) nonprofit. Join or donate to City Club and support the spaces where community and leadership meet.On May 2, 2025, City Club of Portland's Built Environment Issue Committee hosted Rx for Central City Livability: Applying Past Successes at the University Place Hotel and Conference Center. The program explored how Portland's history of visionary public infrastructure—from the Transit Mall to the Pearl District—can inform the city's next chapter of growth and revitalization.The conversation brought together leaders who have helped shape some of Portland's most transformative projects. Together, they reflected on the role of catalytic investments, cross-sector collaboration, and community vision in creating a more livable Central City.Program speakers included: Earl Blumenauer, former U.S. Congressman and Presidential Fellow at the Institute for Portland Metropolitan Studies at Portland State University Michael Alexander, Board Chair for Albina Vision Trust Tiffany Sweitzer, President of Hoyt Street Properties Art Pearce, Deputy Director of Planning, Projects and Program for Portland Bureau of Transportation

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

Renee Shaw recaps the Rx and Illicit Drug Summit 2025 with one-on-one interviews, including U.S. Representative Hal Rogers (R-KY5); U.S. Representative James Comer (R-KY1); U.S. Representative Brett Guthrie (R-KY2); and Nora Volkow, director of the National Institute on Drug Abuse.

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

— IN THE TRANSITS: —April 30   (Wed) Venus ingress Aries: World LoveMay 2   (Fri) Venus conjunct Neptune (0° Aries & 3 of 3): Intuitive ActionMay 4   (Sun) Pluto stations Retrograde: Heading Back Around*No planets Rx for three weeks - (until May 4th!)(Central Time for all dates & times) Book your astrology reading: https://intentionbeads.com/bookUse code ‘PODCAST' for $20 off!Follow along with these transits personally! Download the Astrology Guide: https://intentionbeads.com/products/free-astrology-guideDownload your Natal Chart:https://intentionbeads.com/chart— ON THE HORIZON: —SIGN UP TODAY CWS Patreon CommunitySign up on Patreon: ⁠https://www.patreon.com/chattingwiththestars⁠WATCH NOW Neptune in Aries CWS WebinarSign up on Patreon (Big Dipper & above): ⁠https://www.patreon.com/chattingwiththestars⁠May 7, 2025 Talisman Trunk ShowSign up: https://intentionbeads.com/products/talisman-trunk-show-raffle-1October 4 - 11, 2025 2025 Tuscany, Italy RetreatSign up here: https://intention.wetravel.com/trips/tuscany-retreat-2025-sandy-rueve-intention-beads-27393631— OUR HOUSE: —Sandy & Alex are returning from a family funeral. Listen in as they discuss the amazing & colorful tribute.

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

McConnell talks Trump's tariff policy, what's being learned at the Rx and Illicit Drug Summit, state lawmakers discuss the future of the Artificial Intelligence Task Force, and we hear from Kentucky's new Poet Laureate.

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

CC411: Kail and Lindsie continue their Q&A from last episode. Someone asks what the wildest thing their kid has said, another question has us reminiscing about our favorite childhood cartoons like Hey Arnold!, Rocket Power, and Rugrats. Then, it's real talk about parenting: their hopes for their kids' future careers (Chick-fil-A cashier, anyone?). Lindsie also opens up about navigating the post-divorce dating scene and the unexpected challenges that have come with it. A Listener asks for advice regarding dealing with their, and lastly, a Foul Play involving crapping yourself? A CLASSIC!Thank you to our sponsors!Go Pure: Get 25% Off with code COFFEE at GoPureBeauty.com/Coffee #goPurepodHappy Mammoth: Get 15% off on your entire first order at HappyMammoth.com just use the code COFFEECONVOS at checkoutQuince: Go to Quince.com/coffee to get free shipping and 365-day returns on your next orderRoBody: Find out if you're covered for free at Ro.Co/COFFEECONVOS. Rx only.Shady Rays: Go to ShadyRays.com and use code COFFEE for 35% off polarized sunglasses.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Joe Carroll was our guest for updates and discussions about the gravity RX, multi-planetary vs. interplanetary, space exploration versus prepping for space settlelment, robotic development and more. Lots was said about Musk and his plans for humans to Mars questioning his ability to handle life support, the needed human infrastructure and his timelines. We had multiple callers, a few of which were quite lengthy. The same for emails which I read on air. The Mars Moon debate was rehashed, Starship was discussed in detail along with Artemis and SLS Orion plans. Read the full summary when available at www.thespaceshow.com for this date, Tuesday, April 22, 2025.

Longevity, Success, Healthy Living, and Nutrition Made Simple Join Our Health Club Community FREE https://www.drasa.com/health-club   Visit Us At Our Health Club Retreats https://www.drasa.com/retreats/ It's Dr. Asa Here... Ask Me Your Question! Text Me: 407-255-7076 Call Me: 888-283-7272 Send me a DM: @DrAsa We are here to help you live your best life. You don't have to live lower than your potential for the rest of your life! Also our Health Club Providers are here to help guide and teach you on how quickly you can reach your health and wellness goals at: https://www.drasa.com/find-a-provider

— IN THE TRANSITS: —April 23   (Wed) Sun square Pluto: Stand Down*Sandy's Astro-Interesting Day*April 24   (Thu) Venus conjunct Saturn (3rd Pass): Does She Help?April 26   (Sat) Mars opposing Pluto: Hope It's Not Charged.April 27   (Sun) New Moon (7° Taurus): Has Major Suggestions*No planets Rx for three weeks - (until May 4th!)(Central Time for all dates & times) Follow along with these transits personally! Download the Astrology Guide:https://intentionbeads.com/products/free-astrology-guideDownload your Natal Chart:https://intentionbeads.com/chart— ON THE HORIZON: —SIGN UP TODAY CWS Patreon CommunitySign up on Patreon: ⁠https://www.patreon.com/chattingwiththestars⁠WATCH NOW Neptune in Aries CWS WebinarSign up on Patreon (Big Dipper & above): ⁠https://www.patreon.com/chattingwiththestars⁠WATCH NOW Venus cazimi Sun Talisman Workshophttps://intentionbeads.com/products/talisman-webinar-venus-rx-cazimi-sun-march-22-2025May 7, 2025 Talisman Trunk ShowSign up: https://intentionbeads.com/products/talisman-trunk-show-raffle-1October 4 - 11, 2025 2025 Tuscany, Italy RetreatSign up here: https://intention.wetravel.com/trips/tuscany-retreat-2025-sandy-rueve-intention-beads-27393631— OUR HOUSE: —We have a special guest in the house! Susan Gidel, financial astrologer, is here to talk about the financial market outlook for 2025. Sign up on Patreon: ⁠https://www.patreon.com/chattingwiththestars⁠

A Business Lawyer joins to discuss how prices will change for PlayStation, Nintendo, AMD, and Nvidia. [SPON: Use "brokensilicon“ at CDKeyOffer for $23 Win11 Pro: https://www.cdkeyoffer.com/cko/Moore11 ] [SPON: Get a $10 coupon for Flex PCBs at JLCPCB: https://shorturl.at/mkloy ] [Support the Independent Journalism done by the MLID Team: https://patreon.com/MooresLawIsDead ] 0:00 Greeting and Meeting Hoeg! 02:24 Nintendo's Switch 2 BLUNDERING 24:48 Console Competition is entering a Multipolar World 31:43 Tariff Impacts as of NOW 39:58 Chaos is the problem... 57:22 Will Europe FINALLY get the GPU supply America used to get? 59:52 RX 9060 XT vs RTX 5060 Ti – Who will survive Tariffs better? 1:11:05 How much will prices go up? Will gaming become a luxury? 1:22:19 Lawfare against US Companies in China 1:28:31 Does Intel's New CEO have a China Problem? 1:32:13 Why wasn't Intel Sued over Raptor Lake Failure? 1:39:42 Intel-TSMC Merger, AMD buying Intel 1:45:07 Qualcomm vs ARM Lawfare, 12VHPWR (lack of) Lawsuits Hoeg's Channel: https://www.youtube.com/@HoegLaw/featured Hoeg's Firm: https://hoeglaw.com/ Last time Hoeg was on: https://youtu.be/aaiP7cQPwck?si=Kwp1vZjxEtxWJc7u 12VHPWR Summary: https://www.msn.com/en-ca/lifestyle/shopping/nvidia-rtx-5090-graphics-cards-are-melting-power-cables-again-but-who-s-to-blame-for-this-recurring-gpu-nightmare/ar-AA1z52fK Can New Intel CEO legally run Intel? https://www.reuters.com/technology/intel-ceo-invested-hundreds-chinese-companies-some-with-military-ties-2025-04-10/ Raptor Lake Issues Summary: https://www.theverge.com/24216305/intel-13th-14th-gen-raptor-lake-cpu-crash-news-updates-patches-fixes-motherboards MLID Leak on Raptor Lake Instability: https://youtu.be/ZFE4q35buKs?si=iv1upwEkfQjT3jHw RADEON Gaining GPU Market Share: https://x.com/TechEpiphanyYT/status/1911406225494802456 https://www.theverge.com/news/645276/razer-blade-gaming-laptops-sales-pause-us-tariffs https://www.heise.de/en/news/Asus-Lenovo-and-Co-Notebook-manufacturers-suspend-deliveries-to-the-USA-10346409.html https://www.reuters.com/technology/apple-airlifts-600-tons-iphones-india-to-beat-trump-tariffs-sources-say-2025-04-10/ https://x.com/harukaze5719/status/1909816066676826365 https://videocardz.com/newz/nvidia-geforce-rtx-5070-drops-below-msrp-in-uk-for-the-first-time https://www.bbc.com/news/articles/cy70yxdn8z6o https://blogs.nvidia.com/blog/nvidia-manufacture-american-made-ai-supercomputers-us/ https://mashable.com/article/tariff-news-dell-hp-lenovo-halt-laptop-shipments