FDA Review posts the Federal Register notices for the week ending 10/09/2020.
FDA accepts for review a Foresee Pharmaceuticals 505(b)(2) NDA for Camcevi 42mg, a ready-to-use six-month depot formulation of leuprolide mesylate, in...
FDA grants Beckman Coulter an emergency use authorization for its Access SARS-CoV-2 Immunoglobulin M (IgM) assay.
FDA issues a revised Manual of Policies and Procedures on ANDA Suitability Petitions to clarify certain issues and include minor updates to the proces...
Federal Register notice: FDA withdraws approval of 13 NDAs from multiple applicants after they notified the agency that the drug products were no long...
Federal Register notice: FDA withdraws approval of nine ANDAs from multiple applicants after they notified the agency that the drug products were no l...
FDA tells Intercept Pharmaceuticals that it is evaluating a newly identified safety signal regarding liver disorder for Ocaliva.