Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Reference #: 320-25-113 Product: Drugs Recipient: Recipient Name Ms. Treasure Holston Recipient Title Chief Executive […]

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Reference #: 320-26-06 Product: Drugs Recipient: Recipient Name Mr. James Daniel Bailey Recipient Title Site/Plant […]

On This Page Date: December 16, 2025 Time: 9:00 a.m. – 4:30 p.m. ET Location: Event Location Duke in DC OfficeConference Center 1201 Pennsylvania Ave. NW, […]

Summary Company Announcement Date: October 31, 2025 FDA Publish Date: November 03, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential for Potassium chloride […]

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 […]