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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.
310 Episodes
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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 Support the show www.kulkarnilawfirm.com
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 for years and shapes your career. In this episode we unpack: Why enforcement has shifted toward individual accountabilityHow repeated compliance failures trigger personal liabilityData integrity and why it matters more than everWhy clinical research and...
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, federal purchasing, and how the government quietly reshapes what counts as “healthy.” If you think this is just about fats and grains, think again. This affects prices, marketing claims, and what ends up on kids’ plates. I’m a food and drug lawyer focused...
Episode Description In 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 to the role of FDA as a referee, Dr. Califf explains how regulation really works and why wealth inequality has become the most serious health issue in the United States. Episode Summary What does it really take to run the FDA, and how political should the agency be? ...
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 quietly become a dealbreaker in healthcare acquisitions. What used to be framed as an FDA issue is now actively being enforced by state attorneys general using consumer protection and deceptive trade practice laws. You’ll hear how the end of the FDA shortage ch...
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-world evidence, and genomic datasets are now central to valuation. But unlike traditional IP, data comes with strings attached. Privacy laws, patient consent, and transfer restrictions can quietly determine whether that data is an asset or a liability. In this episod...
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...
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...
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 ...
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...
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...
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...
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...
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...
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 ...
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 ...
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...
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—...
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...
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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