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A new FDA draft guidance outlines how sponsors should develop and evaluate container closure systems and device components used wi...[ Price : $8.95]
A new Harvard Law School legal commentary argues that decades of policies designed to accelerate pharmaceutical innovation may hav...[ Price : $8.95]
FDA classifies a correction involving certain Argon Medical convenience kits as a Class I recall after identifying risks associate...[ Price : $8.95]
A BioProcess International column praises a new FDA final guidance for introducing some flexibilities into approval of cell and ge...[ Price : $8.95]
Two Argent Fox Schiff attorneys describe an FDA proposed rule that would change how some drug manufacturers register their facilit...[ Price : $8.95]
FDAs Cellular, Tissue, and Gene Therapies Advisory Committee votes to recommend approval of Replimune's experimental oncolytic imm...[ Price : $8.95]
Sen. Ron Johnson asks to interview four former CBER officials and Anthony Fauci on the safety and efficacy of Covid vaccines.[ Price : $8.95]
FDA accepts for priority review a Johnson & Johnson supplemental BLA for subcutaneous Rybrevant Faspro for adults with recurrent o...