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Welcome to DarshanTalks! 152254
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.
152254
355 Episodes
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Send us Fan Mail Episode Overview: In this episode of KLF Deep Dive, host Darshan Kulkarni sits down with Deborah Williams, Founder of Health Policy Insights, LLC, to explore over three decades of healthcare policy evolution. Deborah brings a wealth of experience as a policy researcher, former congressional staffer, and former lobbyist to break down the complexities surrounding the 340B Drug Pricing Program, hospital outpatient payments, and legislative mechanics on Capitol Hill. Key Topics C...
Send us Fan Mail The wellness industry is undergoing a massive boom, but modern contrast therapy, thermal bathing, and sauna facilities are stepping directly into an unseen legal grid. In this episode of the Darshan Live podcast, host Darshan Kulkarni sits down with healthcare regulatory attorney Kate Woods and former public defender turned sauna master Mackenzie Boling to pull back the curtain on the regulatory boundaries of thermal wellness. Together, they explore why saunas remain largely ...
Send us Fan Mail When podcast hosts and biohacking influencers promote "The Wolverine Stack"—coupling BPC-157 and TB-500 for rapid tissue and gut repair—it generates millions of dollars in consumer demand. But how does viral influencer marketing translate into real-world legal and regulatory risk? In this episode of Darshan Talks /KLF Deep Dive, host Darshan Kulkarni breaks down the myth versus the science behind BPC-157 (Body Protection Compound-157) and the legal pitfalls facing wellness cl...
Send us Fan Mail What is happening inside the FDA, and how are regulatory shifts impacting pharmaceutical, medical device, and food companies? In this episode of the KLF Deep Dive, host Darshan Kulkarni sits down with veteran Food and Drug lawyer Alan Minsk (Partner and Chair of the Food & Drug Practice at Arnall Golden Gregory LLP) to discuss the evolving enforcement climate, agency turnover, and global supply chain challenges. Together, they break down the structural impact of gove...
Send us Fan Mail Thinking about launching a health tech startup, digital health app, or wearable device? Moving fast and breaking things might work in software, but in healthcare, breaking things means breaking people. In this episode of the KLF Deep Dive, host Darshan Kulkarni connects with Emily Hu Shapiro—a Silicon Valley native, chemical/biomedical engineer, former Google clinical research lead, powerlifter, and startup investor—to bust the myth of the solo "garage startup" in medical dev...
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