DarshanTalks Podcast
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.
- Update frequency
- every 2 days
- Average duration
- 5 minutes
- Episodes
- 267
- Years Active
- 2023 - 2025
Testosterone parties and unapproved biohacks: Is it worth the risk? #darshantalks
We explore the world of biohacking, with a particular focus on the emerging trend of "testosterone parties." These biohacking practices raise concerns regarding safety, efficacy, and misleading prom…
Research Fraudster Banned by the FDA
Mayya Tatsene has been issued a final debarment order by the FDA. The reason for the debarment stems from violating FDA regulations concerning clinical trials. Specifically, Tatsene failed to test o…
How does CTP regulate tobacco? | Micah Berman
The FDA's Center for Tobacco Products (CTP) was created in 2009 to regulate tobacco products. Micah Berman worked at CTP from 2011-2012. He discusses the CTP's evolution in the past decade and share…
60 second reveal: 3 Regulatory authorities that can make or break your pharma or device sale
Darshan Kulkarni emphasizes that companies considering #acquisitions must be ready for scrutiny from multiple agencies: FDA, FTC, DOJ, and OIG. FDA examines various aspects like manufacturing, clini…
Maximizing FDA meetings: Getting the best out of every encounter | Ashley Preston
In this episode, the focus is on planning #FDA meetings and the significance of pre-IND meetings. We discuss how pre-IND meetings are crucial for identifying and addressing any roadblocks or gaps in…
The role of decentralized trials in the traditional landscape | Isaac Rodriguez- Chavez
Isaac Rodriguez-Chavez discusses the role and the significance of the Decentralized Clinical Trials guidance.
We discuss the following:
- What are decentralized clinical trials? - 2:05- 4:25
- What fact…
The Essential Guide to 7 Types of Clinical Trial Agreements
Istvan Fekete and Darshan Kulkarni discuss the 7 types of clinical trial agreements (CTAs). CTAs Explored Include:
- Industry-Sponsored Trials,
- Phase Four and Post-Market Studies,
- Registry Studies,
- F…