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CDERs Office of Generic Drugs Office (OGD) expands its post-pandemic return to in-person face-to-face meetings with industry.[ Price : $8.95]
FDA announces a new pilot program to further accelerate the development of novel drug and biological products for rare diseases. ...[ Price : $8.95]
FDA says it is implementing immediately a new guidance with information about updating susceptibility test interpretive criteria b...[ Price : $8.95]
FDA publishes a draft guidance on the electronic submission format for de novo medical device requests.[ Price : $8.95]
Three people petition FDA to add information from the fluoroquinolone Boxed Warning to the top of the drugs Medication Guide as a ...[ Price : $8.95]
An FDA advisory committee votes 17 to 1 against approving a BrainStorm Cell Therapeutics BLA for NurOwn, an investigational mesenc...[ Price : $8.95]
FDA approves a subcutaneous administration for Takedas Entyvio (vedolizumab) for maintenance therapy in adults with moderately to ...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled Adverse Experience Reporting For Licen...