Four stakeholders voice their support for provisions in the MDUFAS 4 reauthorization agreement.
Federal Register Notice: FDA posts an annual report on the status of postmarketing requirements and postmarketing commitments.
Federal Register Notice: FDA announces the names of the members who will serve on its Performance Review Board that will review senior agency official...
Federal Register Notice: FDA seeks comments on an information collection extension submitted to OMB related to Applications for Participation in the M...
In its latest batch of Warning Letters, FDA cites Dongying Tiandong Pharmaceutical Co. and STI Pharma.
FDA approves a Lupin Ltd. ANDA for armodafinil tablets 50 mg, 150 mg, 200 mg and 250 mg generic versions of Cephalons Nuvigil, indicated to improve w...
FDA accepts for priority review an EMD Serono BLA for avelumab and its use in patients with metastatic Merkel cell carcinoma.
Public Citizen and seven other consumer and government watchdog groups tell FDA that its draft guidance on Procedures for Evaluating Appearance Issues...