CDERs Office of Generic Drugs Office (OGD) expands its post-pandemic return to in-person face-to-face meetings with industry.
FDA announces a new pilot program to further accelerate the development of novel drug and biological products for rare diseases.
FDA says it is implementing immediately a new guidance with information about updating susceptibility test interpretive criteria breakpoints and assoc...
FDA publishes a draft guidance on the electronic submission format for de novo medical device requests.
Three people petition FDA to add information from the fluoroquinolone Boxed Warning to the top of the drugs Medication Guide as a way to better inform...
An FDA advisory committee votes 17 to 1 against approving a BrainStorm Cell Therapeutics BLA for NurOwn, an investigational mesenchymal stem cell ther...
FDA approves a subcutaneous administration for Takedas Entyvio (vedolizumab) for maintenance therapy in adults with moderately to severely active ulce...
Federal Register notice: FDA seeks comments on an information collection extension entitled Adverse Experience Reporting For Licensed Biological Produ...
