CBER director Peter Marks announces he will immediately serve as Office of Vaccines Research and Review (OVRR) acting director, replacing OVRR directo...
Federal Register notice: FDA makes available a draft guidance on developing drugs for treating Nontuberculous Mycobacterial Pulmonary Disease Caused b...
Federal Register notice: FDA makes available a draft guidance entitled Electronic Submission Template for Medical Device 510(k) Submissions.
Pfizer and BioNTech say they will seek in the coming weeks an emergency use authorization from FDA for their Covid-19 vaccine in children ages 5 to un...
FDA issues a draft guidance on the use of two sources of real-world data to support regulatory decision-making.
FDA warns Condemned Labz that it is marketing misbranded unapproved new drugs.
PhRMA tells FDA it appreciates many of the revisions the agency has made to a draft guidance on sponsor responsibilities for safety assessment and rep...
FDA grants priority review to ViiVs cabotegravir to prevent acquisition of HIV in certain men.