Dr. George Tidmarsh had been placed on leave Friday after Health and Human Services officials were notified of the issues, a ...

The director of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, George Tidmarsh, resigned on Sunday amid serious concerns about his personal conduct, a Department of ...

On September 9, 2025, President Trump issued a Presidential Memorandum directing the Secretary of Health and Human Services ...

FDA leaders claimed that publishing hundreds of complete response letters (CRLs) in a central database was embracing "radical transparency," but critics think the move was more about optics, and argue ...

David is managing director at the consulting firm Pharmagellan and professor of the practice in the Tufts University Department of Biology. The U.S. Food and Drug Administration was slammed recently ...

The FDA on Thursday promised to start posting its drug rejection letters shortly after they're issued to the pharmaceutical companies sponsoring the products. The agency also published 89 of the ...

The next time the FDA turns down a drug application, the letter outlining the decision and the regulator’s reasoning will become public record. The agency said it will release future complete response ...

The FDA made waves in early September when it announced a plan to publicly release complete response letters (CRLs) at the same time they are issued to sponsoring companies, part of what the agency ...

Marty Makary is commissioner of the Food and Drug Administration. The letters the Food and Drug Administration sends to pharmaceutical companies explaining its decisions on drugs are a treasure trove ...

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning morning. Today, we learn the FDA is committing to CRL transparency, ...