[ Price : $8.95]
FDA releases the form FDA-483 with six observations from an inspection at Chinas Bio-Thera Solutions.[ Price : $8.95]
FDA awards Partner Therapeutics a Commissioners National Priority Voucher for a new Bizengri indication.[ Price : $8.95]
FDA publishes a guidance explaining how the agency uses a flexible chemistry, manufacturing, and controls approach to help expedit...[ Price : $8.95]
FDA hosts a virtual public meeting later this month to address industry questions tied to a planned pilot program exploring the us...[ Price : $8.95]
FDA posts a new guidance detailing how manufacturers should design and submit regulatory applications for patient-matched guides u...[ Price : $8.95]
Some 30 bipartisan House members urge FDA to expedite its review of new mental health therapies.[ Price : $8.95]
FDA warns Czechias Respilon Production about CGMP violations in its manufacturing of over-the-counter drugs.[ Price : $8.95]
A Bioprocess Online guest column outlines recent changes to FDAs accelerated approval pathway that were made to address systemic f...