For instance, "the backlog of FOIAs ... is enormous," he said. Califf said the FDA has far greater opportunities for improved ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

The FDA's request stems from observations made during recent inspections of Ultragenyx's manufacturing facilities.

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...

The U.S. Food and Drug Administration released more than 200 of its so-called complete response letters from its archive on ...

The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...

The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...

Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...

On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in ...

The FDA published a database containing more than 200 letters to pharmaceutical companies detailing why the agency initially refused to approve their products, The New York Times reported July 10. FDA ...

FDA Commissioner Marty Makary's vision for the agency risks the best of an agency that mostly has functioned well for the ...

The U.S. FDA publishes over 200 complete response letters to enhance transparency within the agency. Read more here.