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
300 episodes
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
Trends in Small Life Sciences Transactions
Darshan Kulkarni in conversation with Nella Bloom, for an in-depth discussion on the current state of small business transactions, private equity trends, and the challenges of advising clients in an unpredictable market.Nella, ...
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12:46
Protect Your Site If a Sponsor Terminates Early
When sponsors terminate a clinical trial early, research sites may face financial losses for preparatory or ongoing work. To mitigate this risk, contracts should explicitly guarantee payment for all work performed up to the termination date,...
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0:59
Are Pharma Chatbots Putting You at Regulatory Risk?
Pharmaceutical chatbots are increasingly used to answer patient drug questions, but they carry significant regulatory and compliance risks. While the FDA has issued guidance on AI in drug development and medical devices, it does not yet prov...
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5:34
Are Your Cosmetic Company Records Ready for FDA Audits?
Companies must maintain thorough records to meet FDA inspection requirements, including safety substantiation files, labeling proofs, ingredient documentation, and adverse event logs. Adverse event logs must be retained for six years (three ...
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1:08
When Medical Affairs Becomes Commercial in Disguise
Darshan explores a critical question for life sciences companies: is your medical affairs team truly independent from commercial—or are you just pretending?In this episode of KLF Deep Dive, Darshan highlights why organizational...
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6:11
Serious Adverse Event Reporting Under MoCRA
Under the Modernization of Cosmetics Regulation Act (MoCRA), reporting serious adverse events to the FDA is now mandatory. Companies must report serious incidents—such as hospitalizations, infections, disfigurement, or medically treated alle...
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1:12
Key SOPs for Clinical Trials
Darshan Kulkarni highlights that to stay compliant with the FDA, companies don’t need an exhaustive set of SOPs—just the essential ones. Inspectors primarily focus on SOPs covering informed consent, adverse event reporting, drug/device accou...
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0:51
Payer Presentations Can Trigger Enforcement
The boundary between scientific exchange and marketing in payer presentations is increasingly blurred, creating significant compliance and enforcement risks. While payers demand real-world evidence, comparative studies, and economic models b...
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6:00
Pharmacies v manufacturers
In this episode, Darshan Kulkarni speaks with Dae Lee about the growing conflict between pharmaceutical manufacturers and pharmacy benefit managers (PBMs) — and how it’s reshaping the U.S. drug supply chain.They unpack the rece...
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11:56
Is Clinical Research Ready for the new FDA?
The FDA has criticized the industry for not taking advertising and promotion seriously and is now cracking down, as evidenced by hundreds of non-compliance letters. This raises the question: if similar scrutiny applied to clinical research, ...
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0:58
Is your cosmetics company FDA-registered?
Cosmetics companies must now register both their facilities and products with the FDA under the new MoCRArequirements, a shift from the previous voluntary system. Each facility must register, and product listings — including categories, ingr...
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1:06
Will AI Replace Doctors in clinical research?
Darshan discusses the potential role of AI in medicine. He believes fears of AI replacing doctors for diagnosis are currently overblown, as trust in physicians remains crucial. However, he suggests AI could assist with preliminary research t...
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0:51
Risks in Direct-to-Patient Engagement
Direct-to-Patient (DTP) models are transforming how medications reach patients, moving beyond clinical research into commercial distribution. Originally developed to help rare disease trial participants avoid long travel to research sites, D...
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2:49
Inside 340B: Challenges, Controversies, and Opportunities
Darshan Kulkarni speaks with Thomas Siepka, CEO of HCI Healthcare Consultants, to take a deep dive into the often-misunderstood world of the 340B drug pricing program. Drawing on Siepka’s extensive experience as a pharmacist and healthcare l...
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14:43