Podcast Episodes
Back to SearchHow 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 2 years 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 2 years 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 2 years 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, 1 month 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, 1 month ago