By Stephanie Brown HealthDay ReporterTHURSDAY, July 10, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has ...

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

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

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

The FDA has published more than 200 complete response letters, sent as replies for applications submitted from 2020 to 2024.

Complete Response Letter (CRL) cited specific chemistry, manufacturing and controls (CMC) related observations that are ...

The FDA accepted Aldeyra's resubmitted NDA for reproxalap after previous rejections due to efficacy concerns, despite no ...

FDA says the move boosts regulatory transparency, offering insights into common approval barriers in drug applications and reducing guesswork.

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

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

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

By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often ...