The presiding officer for a hearing on a CDER proposal to withdraw approval for Covis Makena says the hearing will be held 10/17-10/19.
A Brookings Institution white paper lists six policy changes FDA could make to enhance generic drug competition.
FDA commissioner Robert Califf says a total revamp of the drug accelerated approval program is not needed to answer criticism following a number of dr...
FDA says it is working with the Organization of Economic Cooperation and Development on a whole-of-governments approach to fighting illicit medical pr...
FDA says it is funding a study of patient perceptions of the risk of a specific cancer associated with textured breast implants.
An FDA advisory committee votes unanimously (22 to 0) to recommend the agency grant Moderna an emergency use authorization for its Covid-19 vaccine in...
FDA publishes a draft International Council for Harmonization guidance on quality risk management with no new regulatory expectations.
Federal Register notice: FDA corrects a 5/24 notice on a draft guidance being made available entitled "Blood Pressure and Pulse Donor Eligibility Requ...