DarshanTalks 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.
Episodes
314 episodes
Why Cosmetic Ingredient Names Matter and What MOCRA Really Means - Interview with Heather Bustos
In 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 cosmetic law).We talk about how ingredient naming is no...
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18:09
Compliance Isn’t a Deal Killer… Until It Is - Interview with Stephanie Trunk
Life 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 Schiff, to unpack what’s really dri...
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Season 1
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Episode 2
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25:54
Cosmetic ingredients the FDA doesn’t want you to use
A 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 process
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2:24
Why Federal Agencies Are Targeting Executives
Federal 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 injunctions. Once your name is on that document, it follows you ...
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8:04
Why the New Food Pyramid Matters to You
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 grocery aisles: school meal rules, food labeling, fe...
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1:14
How to Protect Your Medical Practice While Expanding Into Research
Adding a research arm to your medical practice can unlock growth, but it also creates real compliance risk if done wrong. In this episode, Darshan explains how to structure research activities without exposing your core practice to fraud, billi...
Subscriber Episode
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Season 10
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Episode 1
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1:07
Ex FDA Commissioner Robert Califf on FDA Authority, Politics, and the Health Crisis No One Wants to Name
Episode 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 trust. From the loss of Chevron deference t...
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Season 10
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Episode 1
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29:59
Buying a Med Spa? GLP-1 Compliance Can Kill the Deal
GLP-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 episode, Darshan breaks down why GLP-1 compliance has qu...
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8:58
New crown jewel valuing patient data
For 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 data. Longitudinal patient records, real-wo...
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1:10
Training Basics - Legal Essentials for Clinical Trial Sites and PIs
Join Principal Attorney Darshan Kulkarni, Pharm.D., M.S., Esq. for a foundational conversation on the essential legal concepts governing clinical research compliance. Drawing on his extensive background in pharmacy, regulatory affairs, and law,...
Subscriber Episode
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Season 1
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Episode 1
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59:04
Your Staff is trained, but can you prove it?
Staffing 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 training. Competent staff is not enough if training is not...
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0:46
What Happens When a Sponsor Walks Away Early?
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 should insist on to stay protected. He covers guarant...
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0:59
Cosmetic Claims the FDA Hates
Your 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, and influencer mistakes that push cosmetic b...
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6:53
Biggest Legal Mistakes in Influencer Marketing
Influencers 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 brand, and the wrong claim in a single post can trigger...
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0:54
Your Mood, Energy, and Sleep Claims Might Be Regulated
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 risk creeps in. The FDA steps in when your claims impl...
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1:04
Device Fail: The Legal Anatomy of a Faulty Implant Scandal
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 fail. This episode breaks down the Aesculap case, t...
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4:58
5 Documents the FDA Will Demand on Site — Are You Ready?
In this episode of DarshanTalks, you dive into what U.S. Food and Drug Administration (FDA) inspectors will demand when they show up on-site. You walk through the five critical documents every life-sciences or pharma company should have ...
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0:56
Cosmetic Marketing Mistakes That Trigger Regulators
Beauty brands hit trouble when they forget they’re dealing with two regulators, not one. The FDA controls how cosmetics are labeled and when a claim crosses into drug territory. The FTC cares about whether your marketing is truthful, espe...
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1:08
Why Your Clinical Trial Contract Is Leaving Cash on the Table
Clinical research sites lose money when sponsor contracts skip the real costs of running a study. In this episode, Darshan breaks down how to protect your site by building a detailed, task-based budget instead of accepting broad lump-sum paymen...
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1:28
Why Testimonials Can Get Your Brand Sued
Before-and-after photos and glowing testimonials can sell products fast, but they’re also some of the most heavily scrutinized tools in advertising. The FTC requires that any endorsement reflect typical results, and the old “results not typical...
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0:52
How to Get Sponsors to Pay Faster than Net 90
Can I negotiate faster payment terms so I don't run out of cash flow? Many sponsor contracts set 90 to 120 day payment timelines. This, however, cripples cash flow for smaller sites. Now you can try to negotiate net 30 or at least milesto...
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1:00
Compliance Mistakes That Kill Pharma and Biotech Deals
Darshan Kulkarni explores why compliance isn’t just a side issue—it’s often the ultimate dealbreaker in pharma and biotech transactions.When buyers look at acquiring a company in life sciences, they’re not just acquiring assets...
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6:29
Balance FDA Rules with FTC Advertising Requirements
Brands often struggle to balance FDA cosmetic rules with FTC advertising standards. The FDA oversees labeling and determines whether a product is a cosmetic, drug, or soap, while the FTC enforces truth in advertising across all marketing. Cl...
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1:08
Key Clauses in PI Contracts to Review
Many clinical trial site leaders overlook critical risks hidden in physician employment agreements. These contracts often contain clauses that can expose sites to financial, legal, and operational danger if not carefully reviewed....
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6:14
Compliance guru talks practical Insights on Speaker Programs
In this episode, host Darshan Kulkarni speaks with Joseph Keeney about speaker programs in the life sciences industry, exploring practical differences between small and large companies. They highlight that while fundamentals like compliance,...
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13:11