ARTICLE | Regulation
Longtime CDER staffer led ‘regulatory revolution’
By Jeff Cranmer, Executive Editor
December 20, 2024 1:14 AM UTC
Robert “Bob” Temple, who helped revolutionize the ways medical products are developed and regulated, is retiring from FDA after 52 years at the agency’s Center for Drug Evaluation and Research and 55 years in federal service, CDER Director Patrizia Cavazzoni said in an internal memo to staff on Thursday.
Temple and a handful of colleagues created regulatory innovations that many in the biopharma industry take for granted today, such as blinded, controlled clinical trials with prespecified endpoints and statistical analysis plans, the use of a single trial to support approval for some indications, and accelerated approval …
- SEO Powered Content & PR Distribution. Get Amplified Today.
- PlatoData.Network Vertical Generative Ai. Empower Yourself. Access Here.
- PlatoAiStream. Web3 Intelligence. Knowledge Amplified. Access Here.
- PlatoESG. Carbon, CleanTech, Energy, Environment, Solar, Waste Management. Access Here.
- PlatoHealth. Biotech and Clinical Trials Intelligence. Access Here.
- Source: https://www.biocentury.com/article/654528/bob-temple-father-of-modern-fda-set-to-retire