Stakeholders ask FDA to clarify its draft guidance on responses to an FDA-483.
An FDA Federal Register notice requests information from drug developers and academic investigators to support a pilot project focused on novel biomar...
Ipsen withdraws its cancer drug Tazverik (tazemetostat) from the U.S. market after new clinical trial data showed an increased risk of serious seconda...
A March inspection of SCA Pharmaceuticals cites multiple manufacturing and contamination-control deficiencies at its outsourcing facility in Windsor, ...
FDA warns Indias Ashirwad Hospital Center and clinical investigator Mukesh Chandre about failing to obtain informed consent for a bioequivalence study...
FDA seeks public input on ways to expand drug repurposing efforts, aiming to accelerate treatment options for patients with unmet medical needs by ide...
FDA issues updated guidance for companies developing therapies to treat, prevent or reduce recurrence of Clostridioides difficile infection (CDI), out...
An FDA inspection cites multiple quality control and aseptic processing concerns at Staska Pharmaceuticals.
