Federal Register notice: FDA seeks comments on an information collection extension entitled Guidance for Industry on Postmarketing Adverse Event Repor...
Four stakeholders comment to FDA on the agencys draft of a limited population pathway for antibacterial and antifungal drugs.
Four stakeholders give FDA input on a draft humanitarian device exemption guidance.
FDA issues new resources for veterinarians to help them understand opioid problems in the context of a veterinary practice.
FDA approves Vertex Pharmaceuticals Kalydeco (ivacaftor) to include use in children with cystic fibrosis ages 12 to 24 months who have at least one mu...
FDA approves Grifols Procleix Zika Virus assay for detecting the virus in individual or pooled plasma specimens from human donors.
Westminster Pharmaceuticals recalls all lots, within expiry, of its thyroid drugs levothyroxine and liothyronine because they were manufactured using ...
Federal Register notice: FDA announces a 9/20 Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting that will discuss modernizin...