Federal Register notice: FDA posts a draft guidance entitled Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulato...
Federal Register notice: FDA publishes modifications to its list of standards FDA recognizes for use in premarket reviews: Modifications to the List o...
FDA issues a draft guidance on using real-world data and evidence to support NDA and BLA decisions.
FDA publishes a guidance on the types of changes to an approved BLA to be documented in an annual report.
The Justice Department says Entellus Medical and the owner of a Georgia surgical practice will pay $4.2 million to resolve a whistleblowers False Clai...
A CDER Manual of Policies and Procedures outlines policies and responsibilities of meeting participants when they are working remotely and using Web-b...
FDA lifts a clinical hold against an Aprea Therapeutics clinical trial evaluating the combination of its lead compound, eprenetapopt, with acalabrutin...
FDA grants Pfizer and BioNTech an expanded emergency use authorization for their Covid-19 vaccine booster to include individuals 16 years of age and o...