We wanted to know where a widely used prescription drug that treats high cholesterol was manufactured and whether the factory ...

To unpack what the new policy means for drug developers, Fierce Biotech’s Darren Incorvaia sat down with Torrey Cope, a lawyer with Sidley Austin who represents and advises life sciences companies on ...

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 ...

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 ...

When the FDA turns down a drug application, it has historically been up to the drug company to reveal it. These FDA complete response letters, or CRLs, haven not been considered public documents.

In a move towards transparency, the US Food and Drug Administration (FDA) has published more than 200 archived complete response letters (CRLs), which detail reasons for non-approval of drug ...

Amy McCarthy is a former reporter at Eater, focusing on pop culture, policy and labor, and only the weirdest online trends. Just in case you weren’t already worried enough about the state of our food ...

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, ...

On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had ...