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DarshanTalks Podcast

Darshan Kulkarni
FDA
Artificial Intelligence
Kulkarni Law Firm
Food and Drug Administration
Clinical Research
Department Of Justice
Anti-Kickback Statute
Good Clinical Practice
Office Of Inspector General
Regulatory Compliance
FTC
HIPAA
Life Sciences
Cosmetics
Medicare
Healthcare
Perfluorinated Substances
Sponsorship Contracts
Regulation
Influencer Marketing

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 ... more

PublishesDailyEpisodes349Founded7 years ago
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Life SciencesHow ToEducationScience

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Latest Episodes

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Thinking about launching a health product, dietary supplement, or digital health solution in the Australian market? You might want to hit pause before assuming your U.S. or European regulatory strategy will translate. In this episod... more

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What happens when an artificial intelligence chatbot moves past answering basic questions and starts actively pretending to be a licensed psychiatrist? In this episode of the KF Deep Dive, host Daran Carney welcomes premier healthca... more

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Think clinical trial compliance is just a part-time job or a paperwork exercise that can be passed off to a medical assistant? Think again. In this episode of the KF Deep Dive, host Daran Carney sits down with Tom Sepka, CEO of HCI ... more

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How a "Failed" 4-Minute Molecule Created a Trillion-Dollar Cultural Eclipse

Imagine pitching a drug to a room of venture capitalists that is biologically perfect—except for one tiny flaw: the human body completely destroys it in fo... more

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Recent Guests

Elizabeth Litten
Privacy lawyer focusing on health care regulatory law and privacy
Fox Rothschild
Episode: Unlicensed Medical Advice & The Legal Battle Over Character.AI
Phyllis Marcus
Vice President of the National Advertising Division (NAD)
BBB National Program
Episode: Why Your "Physician-Only" Ads Aren't Safe from Regulators
Bruce McCabe
Futurist focused on science, engineering, and innovation for healthcare
Independent futurist
Episode: 10,000 Specialists: A Futurist’s Vision for AI Healthcare
Heather Bustos
FDA compliance attorney and founder of Bustos Law Group
Bustos Law Group
Episode: Why Cosmetic Ingredient Names Matter and What MOCRA Really Means - Interview with Heather Bustos
Stephanie Trunk
Partner at ArentFox Schiff specializing in life sciences regulatory matters
ArentFox Schiff
Episode: Compliance Isn’t a Deal Killer… Until It Is - Interview with Stephanie Trunk
Robert Califf
Former FDA Commissioner, physician-scientist with extensive regulatory and industry experience
Former U.S. Food and Drug Administration (FDA) Commissioner
Episode: Ex FDA Commissioner Robert Califf on FDA Authority, Politics, and the Health Crisis No One Wants to Name

Host

Darshan Kulkarni
Host of the KF Deep Dive (interviewer); Host of the podcast; Host of Darshan Talks Podcast (Powered by Kulkarni Law Firm)

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Talking Points

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Compliance Isn’t a Deal Killer… Until It Is - Interview with Stephanie Trunk
Q: Do you think AI has a role in due diligence as we continue?
AI can help summarize contracts and map data across documents, but it requires careful validation against source documents and awareness of potential inaccuracies.
Compliance Isn’t a Deal Killer… Until It Is - Interview with Stephanie Trunk
Q: Stephanie, before we get started, you want to introduce yourself?
Stephanie Trunk introduces herself as a partner at ArentFox Schiff, specializing in life sciences regulatory issues, including CMS and OIG lens, reimbursement, fraud, and abuse.
Why Your "Physician-Only" Ads Aren't Safe from Regulators
Q: Let me ask you a really simple question: who is a consumer in NAD's view, and how broad is the consuming audience?
A consumer includes not only the end layperson but also healthcare professionals and the broader public who may be exposed to advertising across digital and traditional channels, so the consuming audience is quite broad and context-dependent.
Unlicensed Medical Advice & The Legal Battle Over Character.AI
Q: How important is patient consent when AI handles PHI, and what should be disclosed?
Consent is critical when AI ingests PHI; patients should be informed about data usage, potential data sharing, and the hospital's or clinic's use of AI tools in their care.
Unlicensed Medical Advice & The Legal Battle Over Character.AI
Q: What governance measures should a company implement before releasing an AI tool in healthcare?
Develop a formal AI governance framework, clearly define tool types, establish security/privacy checks, set prohibited and required examination criteria, and ensure proper consent and data handling mechanisms.

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Frequently Asked Questions About DarshanTalks Podcast

What is DarshanTalks Podcast about and what kind of topics does it cover?

A clinically focused regulatory podcast that routinely analyzes the intersections of law, policy, and compliance in life sciences, healthcare, and pharma marketing. Across episodes, the show covers AI in medicine, FDA and OIG oversight, clinical research agreements, data governance, and the evolving regulatory landscape for drug and device development. Guests range from regulatory lawyers to industry practitioners, with practical guidance on governance, liability, and enforcement — often paired with real-world case studies and actionable playbooks for risk management and compliant operations. The show tends to emphasize pragmatic strategies for navigating complex regulatory frameworks while spotlighting emerging topics like AI-driven clinic... more

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Which podcasts are similar to DarshanTalks Podcast?

These podcasts share a similar audience with DarshanTalks Podcast:

1. The New Yorker Radio Hour

How many episodes of DarshanTalks Podcast are there?

DarshanTalks Podcast launched 7 years ago and published 349 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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What guests have appeared on DarshanTalks Podcast?

Recent guests on DarshanTalks Podcast include:

1. Elizabeth Litten
2. Phyllis Marcus
3. Bruce McCabe
4. Heather Bustos
5. Stephanie Trunk
6. Robert Califf

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