DarshanTalks Podcast

Darshan Kulkarni
  • 4.3 (6)
  • LIFE SCIENCES
  • UPDATED WEEKLY

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. 

  1. JAN 29

    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 not just labeling, it’s a strategic business decision that can make or break product marketing. Heather breaks down how the Personal Care Products Council influences naming conventions, why companies struggle to sell ingredients when they can’t describe them well, and what’s actually allowed under FDA rules. We also dive into the Modernization of Cosmetics Regulation Act (MOCRA). We discuss what’s already in effect, what’s still vague, and why this transition period is both confusing and critical. Along the way we share real-world GMP audit stories, how COVID shaped compliance, and why walking the factory floor gives better regulatory insight than just reading guidance documents. This is not your typical cosmetic compliance talk. If you make or sell cosmetics, personal care products, or ingredients, pay attention. Show Notes (Bulleted) What are INCI names and why they existThe Personal Care Products Council and how INCI naming worksHow ingredient naming crosses into marketing strategyReal-world examples of label creativity and regulatory riskMaking sense of MOCRA — what’s live, what’s stuckWhy registration, adverse event reporting, and safety substantiation matter nowWhat we still don’t know about cosmetic GMP enforcementGMP audits vs desk compliance — why experience mattersU.S. vs EU regulatory contrast (quick take)Tips for staying compliant while FDA rules evolveWhat You’ll Learn How to think about ingredient names as part of your product strategyWhat’s actually required vs what’s still vague in cosmetic regulationHow the naming process works with industry groupsHow MOCRA changes the compliance landscapeReal compliance lessons from factory auditsResources Mentioned Personal Care Products CouncilMOCRA (Modernization of Cosmetics Regulation Act)Cosmetic registration and listingAdverse event reporting basicsWho This Is For Cosmetic brand owners and foundersIngredient suppliers and formulatorsRegulatory affairs professionalsLegal and compliance teamsAnyone confused by cosmetic labeling rulesRecommended Chapters (Timestamped) Use these in Buzzsprout chapter markers: 0:00 — Intro  1:30 — What INCI ingredient names are  3:30 — How ingredient naming affects marketing  7:00 — Creative labeling and regulatory limits  10:00 — GMP audits and manufacturing reality  13:50 — What MOCRA is  16:30 — Which MOCRA rules are live  19:00 — What’s still vague or coming  21:30 — EU vs US differences  24:00 — Tips for compliance  27:00 — Outro Support the show www.kulkarnilawfirm.com

    18 min

  2. JAN 22

    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 driving renewed deal activity and what buyers are still missing in diligence. From U.S. manufacturing incentives and drug pricing exposure to China risk, DOJ enforcement, compliance culture, and AI, this conversation goes beyond headlines and into deal reality. If you are buying, selling, or advising life sciences companies, this episode is a must-listen. Key Topics Discussed Why life sciences M&A slowed down and why it’s backThe shift from mega-deals to asset-specific acquisitionsWhy U.S. manufacturing location now affects deal valueAccelerated approvals and “Buy America” incentivesDrug pricing risks buyers can no longer ignoreASP, inflation rebates, Medicaid rebate cap removal, and 340B pressurePolitical risk in drug pricing and government scrutinyChina partnerships, data transfer rules, and biosecurity concernsDirect-to-patient models and new HIPAA exposureUsing Sunshine Act and other public data in diligenceCompliance programs, culture, and successor liabilityWhy compliance issues still rarely kill dealsThe emerging role of AI in diligence and enforcementThe IP diligence problem no one wants to solveWhy This Episode Matters Life sciences deals are no longer just about science and revenue projections. Manufacturing geography, pricing exposure, compliance culture, data security, and enforcement risk now directly shape valuation and post-close outcomes. Ignoring these issues does not make them go away. It just shifts the risk to the buyer. Guest Stephanie Trunk Partner, ArentFox Schiff Life Sciences | CMS | OIG | Reimbursement | Fraud & Abuse Stephanie advises pharmaceutical, biotech, and device companies on regulatory risk, government pricing, and transaction diligence. 📧 stephanie.trunk@afslaw.com  🔗 ArentFox Schiff Life Sciences Blog Host Darshan Kulkarni Founder, Kulkarni Law Firm Host, DarshanTalks 📧 darshan@kulkarnilawfirm.com  🔗 LinkedIn: Darshan Kulkarni Subscribe & Connect If life sciences compliance, enforcement, or deals matter to your business, subscribe for more conversations like this.  Questions or ideas for future episodes? Reach out anytime. Support the show www.kulkarnilawfirm.com

    26 min

  3. JAN 17

    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 Support the show www.kulkarnilawfirm.com

    2 min

  4. JAN 15

    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 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 telehealth are now in regulators’ crosshairsWhat personal obligations look like inside a consent decreeWhat executives should be doing now to protect themselvesIf you lead in an FDA-regulated space, this one matters. Get show notes and resources at www.kulkarnilawfirm.com Subscribe for weekly breakdowns of enforcement trends that actually affect you. Support the show www.kulkarnilawfirm.com

    8 min

  5. JAN 10

    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, 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 on how policy becomes enforcement, and I’ll tell you what you need to know in straight language.  Support the show www.kulkarnilawfirm.com

    1 min

  6. JAN 8

    Ex FDA Commissioner Robert Califf on FDA Authority, Politics, and the Health Crisis No One Wants to Name

    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? Former FDA Commissioner Robert Califf reflects on his path to the role, the skills a commissioner actually needs, and why FDA must act as an impartial referee rather than a political actor. The conversation explores guidance versus regulation, the loss of Chevron deference, industry expertise, the revolving door debate, and how social determinants of health shape outcomes far more than medicine alone. A candid, opinionated look at regulation from someone who has seen every side of it. Key Topics Discussed How Dr. Califf became FDA Commissioner twiceWhy FDA should act as a referee, not a combatantGuidance documents and how they really functionPolitics, policy, and product level decision makingPreparing for the loss of Chevron deferenceWealth inequality as the biggest health problem in the U.S.Social determinants of health and FDA’s roleGeneric drugs, tobacco, and public health impactDigital health hype versus real-world impactThe FDA–industry revolving door debateWhy This Episode Matters As courts, politicians, and industry challenge agency authority, understanding how FDA decision making actually works matters more than ever. This episode explains what regulation can and cannot do, where political pressure becomes dangerous, and why ignoring inequality undermines health outcomes no matter how advanced the science becomes. Guest Robert Califf Former Commissioner, U.S. Food and Drug Administration Instructor in Medicine, Duke University Dr. Califf has served twice as FDA Commissioner and brings decades of experience across clinical medicine, academia, industry, and government. Host Darshan Kulkarni  Founder, The Kulkarni Law Firm  Host, DarshanTalks Call to Action Subscribe for more conversations on FDA regulation, enforcement, policy, and healthcare compliance.  Questions or ideas for future episodes? Call, click, or email. Support the show www.kulkarnilawfirm.com

    30 min

  7. JAN 8

    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 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 changed what compounding pharmacies are legally allowed to do, why “research grade” GLP-1 products are not a workaround, and how recent enforcement actions in Alabama and Connecticut are reshaping diligence expectations. This episode walks through the red flags buyers must catch before signing, including opaque supply chains, misleading marketing claims, research washing, and misaligned informed consent. It also explains why missing these issues can lead to asset freezes, injunctions, multi-state investigations, and massive post-closing remediation costs. If you advise on med spa transactions, private equity healthcare deals, or GLP-1-driven growth strategies, this conversation is essential listening. For deeper diligence support on GLP-1 programs and healthcare transactions, reach out to the Kulkarni Law Firm. Subscribe for more conversations at the intersection of M&A, FDA regulation, state enforcement, and healthcare compliance. Support the show www.kulkarnilawfirm.com

    9 min

  8. JAN 2

    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-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 episode of KLF Deep Dive, we explore why clinical data is being treated as the new IP in biotech M&A, how weak consent frameworks can destroy deal value, and what acquirers should be asking during diligence before it’s too late. If you work in biotech, pharma, corporate development, or private equity, this episode breaks down a risk that is reshaping how deals get priced and structured. Listen in, and reach out if this issue is sitting inside one of your transactions. Episode Highlights Why patents alone no longer drive biotech valuationsHow precision medicine changed the M&A playbookClinical data as a regulated assetPatient consent and data transfer risksWhen valuable datasets become compliance liabilitiesWhat smart buyers are doing differently in diligenceSupport the show www.kulkarnilawfirm.com

    1 min
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Ratings & Reviews

4.3
out of 5
6 Ratings

About

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. 

Information

  • Creator
    Darshan Kulkarni
  • Years Active
    2019 - 2026
  • Episodes
    312
  • Rating
    Clean
  • Copyright
    © 2026 DarshanTalks Podcast
  • Show Website
    DarshanTalks Podcast