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

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 agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...

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

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

While the CRL derails a near-term clearance, one analyst described the rejection as more of “a speed bump to approval, rather ...

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 ...

A paper published in the British Medical Journal, authored by FDA staff, compares content from FDA's complete response letter for a rejected drug, with the subsequent press release by drug developers.