DarshanTalks Podcast
Darshan Kulkarni
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About This Podcast
Welcome to DarshanTalks!
We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!
Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do.
We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
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Recent Episodes
Final LGBTQ Individuals in clinical research
Send a textSupport the showwww.kulkarnilawfirm.com
When the FDA Plays Politics
Send a textIn this episode of KLF Deep Dive, we examine a chilling shift in regulatory enforcement: the weaponization of "Intended Use." If the science hasn't changed and the law hasn't changed, why…
Your Site’s Background Check is Illegally Incomplete - Here is why
Send a textIn this episode, Darshan Kulkarni dives into the terrifying reality of compliance failures at clinical trial sites. While most directors worry about standard fines, the true danger lies in…
Is Your Off-Label Use Now a Federal Crime?
Send a textFor decades, a "clean mental line" existed: Doctors prescribe, and companies don't promote off-label. That line just got a lot messier. In this episode, Darshan Kulkarni breaks down the…
10,000 Specialists: A Futurist’s Vision for AI Healthcare
Send a textIn this episode, we sit down with world-renowned futurist Bruce McCabe to cut through the hype of large language models like ChatGPT and explore the "stunningly optimistic" reality of…
The Battle Over Weight Loss and Compounded Drugs
Send a textIn this episode of DarshanTalks, host and attorney-pharmacist Darshan Kulkarni deconstructs the legal "scorched-earth" offensive currently reshaping the weight loss drug industry.…
Why Cosmetic Ingredient Names Matter and What MOCRA Really Means - Interview with Heather Bustos
Send a textIn this episode, I sit down with FDA compliance attorney Heather Butos to unpack two topics most cosmetic pros ignore until it’s too late: INCI (ingredient) names and MOCRA (the new…
S1E2 Compliance Isn’t a Deal Killer… Until It Is - Interview with Stephanie Trunk
Send a textLife sciences M&A is picking up again, but today’s deals look nothing like they did two years ago.In this episode, Darshan Kulkarni sits down with Stephanie Trunk, Partner at ArentFox…
Cosmetic ingredients the FDA doesn’t want you to use
Send a textA brief discussion on the various cosmetic ingredients used by cosmetic manufacturers and the concerns FDA has recently found as a result of their own study into the processSupport the…
Why Federal Agencies Are Targeting Executives
Send a textFederal enforcement is changing. Regulators aren’t just going after companies anymore. They’re naming CEOs, CMOs, heads of clinical, quality, and operations in consent decrees and…
Why the New Food Pyramid Matters to You
Send a text Everyone’s talking about the new food pyramid like it’s diet advice. I’m here to tell you it’s regulatory policy in disguise. In this episode I break down why this change matters beyond…
S10E1 Ex FDA Commissioner Robert Califf on FDA Authority, Politics, and the Health Crisis No One Wants to Name
Send a textEpisode DescriptionIn this episode, Darshan Kulkarni sits down with former FDA Commissioner Robert Califf for a wide-ranging conversation on FDA authority, politics, guidance, and public…
Buying a Med Spa? GLP-1 Compliance Can Kill the Deal
Send a textGLP-1 weight loss programs are everywhere right now, especially in the med spa space. For M&A lawyers and deal teams, that popularity comes with serious regulatory risk.In this…
New crown jewel valuing patient data
Send a textFor decades, biotech M&A followed a familiar script. Patents drove value. Molecules closed deals.That script is breaking.In today’s precision medicine transactions, the real asset is…
Your Staff is trained, but can you prove it?
Send a textStaffing and training are not just operational issues. They are inspection risks. In this episode, we break down what sponsors and regulators actually expect when it comes to site staff…
What Happens When a Sponsor Walks Away Early?
Send a text Early termination by a sponsor can leave a clinical research site holding the bill for prep work, fees, and staffing. In this episode, Darshan explains the contract language every site…
Cosmetic Claims the FDA Hates
Send a textYour skincare product may look like a cosmetic, but one wrong claim can legally turn it into an unapproved drug.In this episode of KLF Deep Dive, we break down the exact words, phrases,…
Biggest Legal Mistakes in Influencer Marketing
Send a textInfluencers can boost visibility fast, but they also create real regulatory exposure if they go off script. The FTC requires influencers to clearly disclose any material connection to your…
Your Mood, Energy, and Sleep Claims Might Be Regulated
Send a text A lot of brands start with harmless wellness promises like better mood, more energy, or improved sleep. As the business grows, though, marketing often becomes bolder, and that’s where…
Device Fail: The Legal Anatomy of a Faulty Implant Scandal
Send a text A knee implant meant to restore mobility. A surgeon secretly collecting international trips and consulting checks. A device company accused of selling a product they allegedly knew would…
Frequently Asked Questions
DarshanTalks Podcast has published 318 episodes since August 2023, covering topics in Documentary, Education.
DarshanTalks Podcast is currently highly active with new episodes every few days. Average episode length is 6m.
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