Delivery Method: United Parcel Service Product: Drugs Recipient: Recipient Name Mr. Dan Marold Chill6 26 Valley Forge Cir.West Boylston, MA 01583United States Issuing Office: Office of […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Michael Wetzer/Dr. Joseph Antoun Recipient Title Chief Executive Officer/Chief Scientific Officer Sanit Technologies, LLC dba […]

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Alan Wong Recipient Title General Manager BBC Group Limited Yangxia Development ZonePumei TownYunxiao County363300China Issuing Office: […]

Docket Number: FDA-2011-D-0605 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA) is announcing the availability of a […]

For Immediate Release: March 06, 2026 Earlier this week, the U.S. Food and Drug Administration held a meeting with several states to discuss the section 804 […]

Docket Number: FDA-2025-D-1504 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Veterinary Medicine Office of […]

Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review […]

This glossary defines terms that will be used in the series of methodological Patient-Focused Drug Development (PFDD) FDA guidance documents that are required by the 21st […]

On March 5, 2026, the Food and Drug Administration approved teclistamab (Tecvayli, Janssen Biotech, Inc.) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory […]