This article provides insights on how COVID-19 is changing the way FDA approaches interactions with the pharmaceutical industry.
Before the COVID-19 pandemic, FDA advisory committee meetings were big public events, where companies presented their science to a panel of health experts who would then recommend whether the drug should be approved. Now, with the FDA announcing that all meetings – including high-profile FDA advisory committee meetings – will be held virtually until further notice, it presents a unique set of challenges for both the FDA and companies. Jim DiBiasi and Cindy DiBiasi share how companies can best prepare for these make-it or break-it meetings and what they need to do to be as effective remotely as they are in person.
Click here to read more: https://www.pharmamanufacturing.com/articles/2020/a-new-kind-of-fda-meeting/
This article was originally featured online at Pharma Manufacturing on June 10, 2020.