An FDA notice outlines NDA/BLA/ANDA user fee acceptance dates for submissions received during the partial government shutdown.
FDA clears a MediPines 510(k) for the MediPines Gas Exchange Monitor, which is intended for real-time pulmonary parameters and insights to support rap...
Researchers say most doctors surveys are concerned about FDA accelerated drug approvals and dont like eased restrictions on off-label marketing.
FDA releases its latest batch of Warning Letters that include Hangzhou Guoguang Touring Commodity Co. and University of Miami Reproductive and Fertili...
FDA issues a guidance extending the implementation date for electronic format submissions of Type 3 drug master files.
Morgan Lewis attorneys say FDA promises to write rules in the future to better align its human subject protection regulations with the new federal Com...
FDA approves an I-Mab Biopharma IND for TJC4, a human anti-CD47 monoclonal antibody for cancer immunotherapy.
FDA approves a Promius Pharma NDA for Tosymra (sumatriptan nasal spray) 10 mg, indicated for the acute treatment of migraine with or without aura in a...