Federal Register notice: FDA withdraws approval of five NDAs because the drug products are no longer marketed.
Stakeholders express appreciation for FDA public sessions on implementing the Drug Supply Chain Security Act and offer suggestions for improvements.
FDA approves an AstraZeneca NDA for Bydureon (exenatide extended-release) for injectable suspension as an add-on therapy to basal insulin in adults wi...
Industria Farmacutica Andrmaco (Toluca, Mexico) recalls topical drug product Pasta De Lassar Andromaco zinc oxide diaper rash treatment after an FDA l...
Stakeholders ask FDA for changes to a draft guidance on CLIA and 510(k) waivers.
Vertice Pharma petitions FDA to revise and make more stringent bioequivalence requirements outlined in its Draft Guidance for Sucralfate Oral Suspensi...
Federal Register notice: FDA issues an order withdrawing approval of ANDAs for certain prescription laxatives with the active ingredient polyethylene ...
FDA and the International Medication Safety Network announce a 6/19-20 international summit on medication safety issues.