Podcast Episodes
Back to SearchTestosterone 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…
Published on 1 year, 11 months ago
Generative AI…confidently spews BS!
AI expert Dave Bulger, delves into the world of #AI, highlighting the distinction between AI and large language models (LLMs). He exposes the limitations of generative AI, raises concerns about copy…
Published on 1 year, 11 months ago
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…
Published on 1 year, 11 months ago
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…
Published on 1 year, 11 months ago
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…
Published on 1 year, 11 months ago
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…
Published on 1 year, 11 months ago
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…
Published on 1 year, 11 months ago
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:
Published on 2 years ago
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…Published on 2 years ago