FDA accepts for review a Bristol Myers Squibb NDA for CC-486, an investigational oral hypomethylating agent for the maintenance treatment of adult pat...
Alliance for a Stronger FDA says the vaccines development industry is likely to see a renaissance under pressure from the Covid-19 pandemic.
FDA grants Gilead Sciences an emergency use authorization for its antiviral drug remdesivir for treating suspected or laboratory-confirmed Covid-19 in...
Three stakeholders comment for the FDA docket on updating the agency data strategy.
CDER issues a MAPP on its approach to newly identified safety signals in marketed drugs.
Federal Register notice: FDA seeks comments on an information collection extension entitled Information Sharing Among Constituent Part Applicants 21 ...
Federal Register notice: FDA makes available a final guidance entitled Temporary Policy Regarding Accredited Third-Party Certification Program Onsite ...
Federal Register notice: FDA postpones a 6/9-planned Ophthalmic Devices Panel of the Medical Devices Advisory Committee meeting that was going to revi...