AdvaMed makes five suggestions to help FDA improve revised Accreditation Scheme for Conformity Assessment guidances.
FDA medical reviewers share with the Endocrinologic and Metabolic Drugs Advisory Committee their concerns about an increased risk of hypoglycemia in T...
FDA Oncology Drugs Division director Harpreet Singh leaves the agency to join Precision for Medicine as chief medical officer.
Public Citizen sues FDA to force it to act on a six-year-old petition seeking labeling changes for SSRIs and SNRIs to highlight the risk of sexual sid...
FDA says the Hologic recall (correction) of BioZorb markers is Class 1.
Magellan Diagnostics (Billerica, MA) agrees to pay $40 million to resolve criminal charges relating to its concealment of a device malfunction that pr...
PhRMA says it supports FDA and the International Council for Harmonization revision of the E2D guidance on post-approval case safety reporting.
FDA warns Rosenberg, TX-based Seatex about CGMP violations in its manufacturing of finished drugs.
