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DarshanTalks Podcast

DarshanTalks Podcast

De : Darshan Kulkarni
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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.

© 2026 DarshanTalks Podcast
Science Sciences sociales
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    Épisodes
    • Futurist Bruce McCabe: How Narrow AI is Solving Healthcare’s Biggest Problems
      Feb 23 2026

      In this episode, we sit down with world-renowned futurist Bruce McCabe to cut through the hype of large language models like ChatGPT and explore the "stunningly optimistic" reality of Specialist (Narrow) AI.

      Bruce shares insights from his global travels to research labs, explaining why the future of medicine isn’t one "God-like" AI, but rather a "hive mind" of tens of thousands of highly trained, testable, and trustworthy specialist systems. From early tumor detection in radiology to the revolutionary protein-folding predictions of AlphaFold, we discuss how AI is incrementally building toward a more precise and efficient healthcare system.

      Key Discussion Points:

      • Moving Beyond the Hype: Why the current "AI correction" is only about large language models, and why narrow AI is actually underhyped.
      • The Power of Specialist Systems: How AI trained on specific datasets (like 100,000 X-rays) achieves higher reliability and lower false-positive rates than general models.
      • The "Hive Mind" Concept: A future where thousands of specialist AIs interact to provide comprehensive patient care while maintaining data anonymity.
      • Trust and Testing: How we measure the trustworthiness of AI in dermatology and diagnostics through historical clinical data.
      • Edge Computing & Privacy: Solving the patient privacy dilemma by using Small Language Models (SLMs) that live on local hospital servers rather than the cloud.
      • The Next Frontier: The role of AI in material science, drug construction, and programmable medicines like CAR T-cell therapy.

      About Our Guest:

      Bruce McCabe is a futurist, speaker, and author who spends half the year visiting scientists and innovators around the world to understand how technology will shape our future. You can find his research and book him for speaking engagements at BruceMcCabe.com.

      Support the show

      www.kulkarnilawfirm.com

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      14 min
    • The Battle Over Weight Loss and Compounded Drugs
      Feb 16 2026

      In this episode of DarshanTalks, host and attorney-pharmacist Darshan Kulkarni deconstructs the legal "scorched-earth" offensive currently reshaping the weight loss drug industry. Following the February 2026 announcement that the GLP-1 shortage is officially resolved, the "Golden Age" for compounders has vanished overnight, leaving companies like Hims & Hers in the crosshairs of both the FDA and Novo Nordisk.

      Darshan takes us from the tragic "ghost" of the 2012 NECC fungal meningitis outbreak to the modern-day "Compounding Wild West." We explore the crucial differences between Section 503A and 503B pharmacies and why adding Vitamin B12 to a patented molecule isn't the "customization" compounders claim it is.
      Key topics include:

      • The NECC Legacy: How a 2012 tragedy created the Drug Quality and Security Act (DQSA) and why the FDA is using it to end the mass-marketing of copycat drugs.
      • The Science of the "Bluff": Why "not adulterated" does not mean "safe and effective" under the FD&C Act.
      • Novo Nordisk vs. Hims & Hers: The billion-dollar patent battle and why the DOJ is now getting involved.
      • The Shortage Shield: What happens to telehealth platforms the moment the FDA "Shortage" flag disappears.

      Don't let your healthcare be decided by an Instagram ad. Understand the intersection of biochemistry and federal law to protect your health and your practice.

      Support the show

      www.kulkarnilawfirm.com

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      15 min
    • Why Cosmetic Ingredient Names Matter and What MOCRA Really Means - Interview with Heather Bustos
      Jan 29 2026

      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 exist
      • The Personal Care Products Council and how INCI naming works
      • How ingredient naming crosses into marketing strategy
      • Real-world examples of label creativity and regulatory risk
      • Making sense of MOCRA — what’s live, what’s stuck
      • Why registration, adverse event reporting, and safety substantiation matter now
      • What we still don’t know about cosmetic GMP enforcement
      • GMP audits vs desk compliance — why experience matters
      • U.S. vs EU regulatory contrast (quick take)
      • Tips for staying compliant while FDA rules evolve

      What You’ll Learn

      • How to think about ingredient names as part of your product strategy
      • What’s actually required vs what’s still vague in cosmetic regulation
      • How the naming process works with industry groups
      • How MOCRA changes the compliance landscape
      • Real compliance lessons from factory audits

      Resources Mentioned

      • Personal Care Products Council
      • MOCRA (Modernization of Cosmetics Regulation Act)
      • Cosmetic registration and listing
      • Adverse event reporting basics

      Who This Is For

      • Cosmetic brand owners and founders
      • Ingredient suppliers and formulators
      • Regulatory affairs professionals
      • Legal and compliance teams
      • Anyone confused by cosmetic labeling rules

      Recommended 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

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      18 min
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