[ Price : $8.95]
FDA warns Indias Reliance Life Sciences about significant CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA warns Jabil Inc. about significant CGMP violations at its Pharmaceutics International unit in Cockeysville, MD.[ Price : $8.95]
Novartis and Bristol Myers Squibb confirm to BioSpace that they are suspending some CAR T candidate trials to evaluate adverse eve...[ Price : $8.95]
FDA adds a new frequently asked questions section to its Web page on PFAS (per- and polyfluoroalkyl substances) in medical devices...[ Price : $8.95]
FDA releases a draft guidance entitled Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, a...[ Price : $8.95]
An appeals court appears to have raised the bar for generic drugmakers seeking to preserve 180-day marketing exclusivity after mis...[ Price : $8.95]
FDA and the International Coalition of Medicines Regulatory Authorities complete an assessment of a new biologics testing approach...[ Price : $8.95]
Researchers say clear rules are needed for when FDA decides to publicly release complete response letters.