December 18, 2025
FDA conducts inspections to evaluate compliance with risk evaluation and mitigation strategies (REMS) requirements to ensure the drug’s health benefits outweigh the risks for patients. Inspections […]
December 18, 2025
Docket Number: FDA-2023-D-5021 Issued by: Guidance Issuing Office Office of Inspections and Investigations Office of the Commissioner, Office of Clinical Policy and Programs Center for Biologics […]
December 18, 2025
For Immediate Release: August 25, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the […]
December 18, 2025
Share on PinterestDoctors have raised concerns that delaying the hepatitis B shot for newborns will likely increase the risks of chronic conditions for children. San Francisco […]
December 18, 2025
Share on PinterestAn FDA panel has called for an easing of restrictions on testosterone replacement therapy (TRT). Image Credit: Malorny/Getty Images A Food and Drug Administration […]
December 18, 2025
Share on PinterestResearch suggests that there’s a lack of evidence for some of the common uses of medical cannabis. Image Credit: JENS SCHLUETER/Getty Images A recent […]
December 17, 2025
On December 17, 2025, the Food and Drug Administration (FDA) approved rucaparib (Rubraca, pharmaand GmbH) for adults with a deleterious BRCA mutation (BRCAm) (germline and/or somatic)-associated […]
December 16, 2025
Historically, serious injuries and deaths have been associated with the use of contaminated heparin. FDA expects all imported heparin sodium lots to be compliant with the […]
December 16, 2025
By clarifying FDA’s regulatory expectations for new entrants and experienced drug developers alike, FDA is supporting prospective generic drug developers and improving the overall quality of […]
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