ARTICLE | Politics, Policy & Law
FDA’s Cavazzoni says conflict-of-interest rules limit expertise on advisory committees
FDA, BIO are launching initiatives to consider improvements to the advisory committee process
June 15, 2021 12:12 AM UTC
FDA’s Center for Drug Evaluation and Research and BIO have launched separate initiatives aimed at injecting more relevant expertise into the FDA advisory committee process and making the meetings more focused on science and less on emotion.
CDER Director Patrizia Cavazzoni and Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER), described their concerns about advisory committees at a BIO Digital session broadcast Monday. The session, moderated by Richard Pops, chairman and CEO of Alkermes plc (NASDAQ:ALKS), was recorded on May 27. ...