Podcast Episodes
Back to SearchInstagram Post that Sparked FDA Warning Letter
In this episode, Darshan Kulkarni unpacks the May 29, 2025 FDA Warning Letter issued to Sprout Pharmaceuticals. The trigger? A promotional Instagram post from the company's CEO calling Addyi “the sex…
Published on 4 weeks ago
Why Are So Many Doctors Getting Arrested?
Why are headlines suddenly filled with stories of doctors, nurses, healthcare executives—and even accountants—being arrested for fraud? In this explosive episode of Daran Talks, we dive into what the…
Published on 4 weeks, 2 days ago
How to Run Compliant Pharma Speaker Programs
What really happens behind the scenes of pharmaceutical speaker programs—and why should smaller pharma companies care? In this episode of DarshanTalks, Darshan Kulkarni unpacks one of the most misund…
Published on 1 month ago
Are You Picking the Wrong KOLs?
Darshan Kulkarni and Edye Edens tackle the complexities of identifying and working with Key Opinion Leaders (KOLs) in clinical research. While KOLs can bring valuable expertise to a therapeutic area,…
Published on 1 month ago
How KLF’s Client Base Evolved Over 20 Years
Edye Edens interviews Darshan Kulkarni about the evolution of the Kulkarni Law Firm (KLF). Darshan reflects on how he originally envisioned working with large pharmaceutical and device companies, but…
Published on 1 month ago
FDA Pushback on Accelerated Gene Therapy Approvals
In this episode, Edye Edens dives into the FDA’s evolving scrutiny of accelerated approvals in gene therapy and rare diseases. Using the example of Sarepta’s muscular dystrophy treatment, she explain…
Published on 1 month, 1 week ago
Your DEI Program Could Trigger an FCA Case
Darshan Kulkarni breaks down the Department of Justice’s new Civil Rights Fraud Initiative, launched on May 19, 2025, and why it should be on the radar of every pharmaceutical and medical device comp…
Published on 1 month, 1 week ago
Teva’s Charity Partnership Scrutinized
A recent $425 million settlement involving Teva Pharmaceuticals highlights the legal and ethical risks charities face when partnering with pharmaceutical companies. Teva was accused of using a charit…
Published on 1 month, 1 week ago
Is There a “Right” Way to Calculate FMV?
Darshan Kulkarni and Edye Edens take a deep dive into one of clinical research’s most persistent questions: how is fair market value (FMV) actually determined for clinical trial sites—and who gets to…
Published on 1 month, 2 weeks ago
Can Non-Physicians Own Clinical Trial Sites?
Can non-physicians own independent clinical trial sites? The answer isn’t as simple as it seems. In most states, including Texas, engaging in clinical research is considered the practice of medicine,…
Published on 1 month, 2 weeks ago