It’s worse than you think. Dr. Jane Ruby, a scientist with over 20 years of experience in regulatory processes for drug approval with the FDA, explains several important ways that the FDA and the drug companies violated the most basic safety protocols at every stage of the development, manufacturing, and surveillance of the experimental shots. The FDA has be ... Show More
Oct 2023
#341: What NOT to say to FDA
Description:Dive into the enlightening world of FDA inspections with Etienne Nichols and Mike Drues. In this comprehensive episode, the duo decodes the essence of effective communication, the importance of managing expectations, and the art of proactive dialogue with the FDA. The ... Show More
49m 11s
Nov 2023
#342: Planning an FDA Submission
Description:In this episode, Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, dives deep into the complexities of FDA submissions for medical devices. She sheds light on the nuances of different submission types, such as ... Show More
38m 53s