On This Page Date: October 9, 2024 Time: 1:00 PM – 3:00 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT (Hosted […]

On This Page Date: October 10, 2024 Time: 8:15 AM – 5:30 PM ET Location: Event Location FDA HeadquartersFDA headquarters in White Oak, MD 10903 New […]

FDA is aware of the devastating impact Hurricane Helene had to Baxter International’s North Cove manufacturing facility in Marion, North Carolina. Our thoughts go out to […]

Issued by: Guidance Issuing Office Human Foods Program Office of Inspections and Investigations Center for Devices and Radiological Health Center for Drug Evaluation and Research BACKGROUND: […]

For Immediate Release: October 01, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

Docket Number: FDA-2008-D-0610 Issued by: Guidance Issuing Office Human Foods Program Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug […]

Delivery Method: VIA UPS Product: DrugsFood & Beverages Recipient: Recipient Name Nathaneal Mohr Recipient Title CEO The Truth Company, LLC 6325 Spine RdBoulder, CO 80301United States […]

Image CaptionElectronic health records are an important part of post-dispensing medical countermeasure monitoring and assessment Background | FDA Guidance & Regulatory Information | Contact | FDA […]

Recently cleared IVD devices, including Antimicrobial Susceptibility Test (AST) devices, include: February 15, 2024: The FDA cleared the PBC [positive blood culture] Separator with Selux Antimicrobial Susceptibility […]