Four stakeholders recommend ways FDA can improve a draft guidance on leveraging prior knowledge in developing some human gene therapy products.
FDA warns Indias Reliance Life Sciences about significant CGMP violations in its production of finished drugs.
FDA warns Jabil Inc. about significant CGMP violations at its Pharmaceutics International unit in Cockeysville, MD.
Novartis and Bristol Myers Squibb confirm to BioSpace that they are suspending some CAR T candidate trials to evaluate adverse events that included de...
FDA adds a new frequently asked questions section to its Web page on PFAS (per- and polyfluoroalkyl substances) in medical devices, saying it has foun...
FDA releases a draft guidance entitled Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage.
FDA warns Fresenius Medical Care North America about CGMP violations at its Ogden, UT, drug manufacturing facility.
FDA posts two guidance documents on dental composite resins and curing lights.
