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PODCAST

DarshanTalks Podcast

Darshan Kulkarni

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

science life sciences

All Episodes

0:46

Your Staff is trained, but can you prove it?

DarshanTalks Podcast ·

2025/12/26

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 documented. We walk through common failure points seen during FDA inspections, including missing GCP documentation, unclear staff roles, and poor escalation processes. We also discuss how structured SOPs, training logs, and clear contracts with coordin...

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0:59

What Happens When a Sponsor Walks Away Early?

DarshanTalks Podcast ·

2025/12/23

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 guaranteed payment for all work performed up to the termination date, reimbursement for non-cancelable expenses like IRB fees and advertising, and why a wind-down clause is essential for chart reviews, final visits, and data queries. He also explores when mini...

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6:53

Cosmetic Claims the FDA Hates

DarshanTalks Podcast ·

2025/12/22

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 brands straight into FDA drug territory. Anti-inflammatory claims. Acne treatment language. Collagen rebuilding promises. Detox buzzwords. These are not harmless marketing fluff. They are regulatory landmines. We explain how the FDA actually classifies products, why ...

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0:54

Biggest Legal Mistakes in Influencer Marketing

DarshanTalks Podcast ·

2025/12/18

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 enforcement or lawsuits. In this episode, I explain how I build influencer contracts with mandatory disclosure language, claim restrictions, and takedown rights. I also describe how I design monitoring systems so brands can review influencer content be...

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1:04

Your Mood, Energy, and Sleep Claims Might Be Regulated

DarshanTalks Podcast ·

2025/12/11

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 imply treating or preventing a disease, which can flip your product into drug or device territory. The FTC expects every wellness claim to be truthful and supported by real evidence. In this episode, I explain how I review labels, websites, and social conte...

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4:58

Device Fail: The Legal Anatomy of a Faulty Implant...

DarshanTalks Podcast ·

2025/12/10

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, the $38.5M settlement, and what it teaches us about kickbacks, forged FDA documents, and the catastrophic cost of weak compliance controls. If your team works in pharma, med-tech, or clinical research, you don’t want to miss this one. Support the s...

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0:56

5 Documents the FDA Will Demand on Site — Are You Ready?

DarshanTalks Podcast ·

2025/12/09

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 ready, because without them, an inspection can become a deal-breaker fast. You stress that compliance isn’t just paperwork; it’s the backbone of long-term viability. A weak document trail, sloppy record-keeping, or missing records can lead to penalties, regula...

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1:08

Cosmetic Marketing Mistakes That Trigger Regulators

DarshanTalks Podcast ·

2025/12/04

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, especially online, and expects competent and reliable scientific evidence for every objective claim you make. Say “clinically proven” without real clinical data and both agencies may come knocking. In this quick breakdown, I explain how to align your claims...

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1:28

Why Your Clinical Trial Contract Is Leaving Cash on...

DarshanTalks Podcast ·

2025/12/02

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 payments. He explains why every activity needs to be itemized, from screen failures and pharmacy prep to coordinator overtime and regulatory time. You’ll hear practical tips on tying costs to CPT codes, adding overhead where possible, and making sure you can ...

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0:52

Why Testimonials Can Get Your Brand Sued

DarshanTalks Podcast ·

2025/11/29

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” fine print no longer cuts it. In this episode, I explain how I review and edit testimonials for compliant disclosures, how I evaluate before-and-after images for accuracy, permissions, and unintentional manipulation, and how I help brands build clear ...

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1:00

How to Get Sponsors to Pay Faster than Net 90

DarshanTalks Podcast ·

2025/11/27

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 milestone-based payments. That means that there's a startup fee paid upon contract execution, quarterly payments regardless of enrollment pace, but the truth is you're not going to get very far with it. Enforcement is just tough. Another tool is an interest-on...

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6:29

Pharma merger killers

DarshanTalks Podcast ·

2025/11/14

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, patents, or promising pipelines. They’re also taking on the company’s regulatory baggage. If that baggage includes off-label promotion, billing fraud, improper trial oversight, or weak documentation, the deal could be dead on arrival. Darshan explains how regulators—...

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1:08

Balance FDA Rules with FTC Advertising Requirements

DarshanTalks Podcast ·

2025/11/12

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. Claims like “clinically proven” require solid scientific evidence, and overreaching claims can trigger scrutiny from both agencies. For growing brands—especially those investing in digital marketing—regulatory compliance is essential. Aligning marketing clai...

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6:14

Key Clauses in PI Contracts to Review

DarshanTalks Podcast ·

2025/11/10

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. Key Risks to Watch Out For: Compensation Structures: Incentives tied to patient enrollment can raise anti-kickback and fraud concerns. Payments should reflect fair market value for time and expertise, not results. Data Ownership: If not explicit, investigators may ...

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13:11

Compliance guru talks practical Insights on Speaker...

DarshanTalks Podcast ·

2025/11/07

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, pragmatism, and sound business principles apply across organizations, strong mitigating controls and adherence to legal and industry codes are critical. Joseph explains the importance of engaging with various business units to understand real plans, align...

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12:46

Trends in Small Life Sciences Transactions

DarshanTalks Podcast ·

2025/11/05

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, an experienced attorney specializing in mergers and acquisitions and fractional general counsel services, explains how today’s business climate feels increasingly unstable. Rapid regulatory changes, unpredictable government responses, and evolving funding structures ha...

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0:59

Protect Your Site If a Sponsor Terminates Early

DarshanTalks Podcast ·

2025/11/03

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, as well as reimbursement for non-cancellable expenses such as IRB fees, recruitment advertising, and staff training. Including a wind-down clause ensures compensation for necessary closeout activities—such as patient chart reviews, final visits, and data ...

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5:34

Are Pharma Chatbots Putting You at Regulatory Risk?

DarshanTalks Podcast ·

2025/11/01

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 provide a framework for patient-facing drug Q&A. That means chatbots that discuss side effects, dosing, or interactions exist in a gray zone, and any missteps could trigger FDA enforcement. The FTC enforces truth in advertising and consumer protection. Mis...

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1:08

Are Your Cosmetic Company Records Ready for FDA Audits?

DarshanTalks Podcast ·

2025/10/30

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 for small businesses), while registration and product listing records require annual updates. Organized, accessible, and up-to-date records are essential not only for compliance but also for growth, due diligence, and investor confidence. Compliance is a s...

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6:11

When Medical Affairs Becomes Commercial in Disguise

DarshanTalks Podcast ·

2025/10/24

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 charts alone are not enough to satisfy regulators. He explains that regulators focus on conduct, process, and intent, not PowerPoint slides. Using the 2013 GlaxoSmithKline settlement as a cautionary example, he demonstrates how blurred lines between medical and commer...

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293 results

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