Action The U.S. Food and Drug Administration (FDA) approved Kygevvi (doxecitine and doxribtimine) powder to treat thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients […]

  Online Advisory Letter Reference #715029 September 10, 2025 Quit Kit, LLC3304 Selwyn Farms Lane, Unit 3Charlotte, NC [email protected] # 718-974-8797 Dear Matthew von Boecklin: This […]

On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022. This new law includes the second reauthorization of the […]

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, […]