Read FDA’s assessment of the benefit/risk considerations regarding the use of ingestible fluoride drug products in children. View the meeting summary, download presentations and watch the […]

FDA’s Postmarketing Requirements and Commitments Searchable Database provides information to the public on postmarketing requirements and commitments. This searchable database includes PMRs and 506B PMCs which […]

On This Page Date: February 22, 2024 Time: 11:00 a.m. – 3:00 p.m. ET Topics & Presentations Speakers Joint US FDA – Health Canada ICH Public […]

Docket Number: FDA-2011-D-0605 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of New Drugs, Office of Therapeutic Biologics and Biosimilars FDA is […]

On This Page Date: November 6, 2025 Time: 9:00 a.m. – 3:00 p.m. ET Location: Event Location FDA HeadquartersFDA White Oak Campus 10903 New Hampshire Ave, […]

On This Page Date: November 6, 2025 Time: 9:00 a.m. – 3:00 p.m. ET Location: Event Location FDA HeadquartersFDA White Oak Campus 10903 New Hampshire Ave, […]

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Reference #: 320-26-07 Product: Drugs Recipient: Recipient Name Mr. Robert Kibbe Recipient Title President and […]

On October 24, 2025, the Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute myeloid leukemia with […]

Delivery Method: VIA UPS Reference #: 320-25-115 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Prakash C. Purohit Recipient Title President/Owner Naturich Cosmetique Labs 2505 Merritt […]