FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes 8 to 8 on whether to recommend approval for Lexicon Pharmaceuticals Inc and Sanofis s...
FDA issues a guidance to help drug and biological product applicants develop the Indications and Usage section of labeling for products approved under...
FDA releases a draft International Council for Harmonization guidance on nonclinical safety testing of pediatric drugs.
FDA releases a guidance explaining the agencys Safety and Performance Based Pathway as an alternative approach for 510(k) submissions.
Attorney Mark Schwartz explores enforcement options open to FDA following expiration of the enforcement discretion period for stem cell facilities it ...
CBS News profiles an FDA food safety investigator whose care for his autistic son is threatened because he has been furloughed from the agency.
FDA clears a 23andMe 510(k) for the MUTYH-Associated Polyposis report, a genetic health risk report on a hereditary colorectal cancer syndrome.
FDA grants Albireo Pharma an orphan drug designation for A4250, an ileal bile acid transporter inhibitor for treating biliary atresia.