Pharmaceutical Policy

Hearing request from Alston & Bird LLP (on behalf of ANI Pharmaceuticals, Inc.)

Hearing request from Hyman, Phelps & Mcnamara, P.C. (on behalf of Syntho Pharmaceutical, Inc.)

Response Letter

Vanda Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon)

Interim Response

Interim Response

Interim Response to Wiley Rein LLP

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients) and the Advanced Manufacturing Technologies Designation Program

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience/Events With Approved New Animal Drugs

Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments

Citizen Petition from HQ Pharma (Shanghai) Co., Ltd.

Response Letter from FDA CDER to HQ Pharma (Shanghai) Co., Ltd.