Dockets
Federal rulemakings, soonest-closing first — each gathers its documents and comments.
Agency ▾
Federal Notice of Intent to Prepare an Environmental Impact Statement (EIS): Washington County, Maine
Meeting on Listeria monocytogenes Prevention
Requests that FDA declare that Ezetimibe and Simvastatin Tablets, 10 mg/15 mg & 10 mg/30 mg, are suitable for submission as ANDA. Petition used Organon LLC’s VYTORIN (ezetimibe and simvastatin) Tablets, approved for prescription under (NDA) 021687 in 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, & 10 mg/80 mg strengths. Petitioner seeks new strengths 10 mg/15 mg and 10 mg/30 mg for prescription use.
Revisions to User Fees for Export and Investment Promotion Services/Events
35 awaiting analysis
Notice; Request for Comments on FDA Rare Disease Innovation Hub Future Programming
1 awaiting analysis
Notice of Establishment of Emergency Relief Docket for Calendar Year 2026
2026-NM-XXXX
1 awaiting analysis
Pilot Program Changes to Fast Track Settlement (Announcement 2025-6)
Data Request: Use of the pH Cycling Test Model as a Testing Procedure for Fluoride Dentifrice Drug Products in Over-the-Counter (OTC) Monograph M021: Anticaries Drug Products for Over-the-Counter Human Use
Draft Update to Voluntary Safety Guidance for Automated Driving Systems (ADS)
Animal Drug User Fee Act; Public Meeting
5 awaiting analysis
Animal Generic Drug User Fee Act; Public Meeting