[ Price : $8.95]
FDA launches a pilot program using one-day inspectional assessments as part of a broader effort to modernize its oversight model a...[ Price : $8.95]
FDA commissioner Marty Makary says the agency is undertaking a major hiring push and a series of operational reforms aimed at stre...[ 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.