The FDA's decision to publish complete response letters (CRLs) amounted to little more than a repackaging of existing information, but now it has gone a step further. The latest batch of CRLs to be ...

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

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 ...

Increasing CRLs from the FDA highlight CMC and analytical deficiencies, often surfacing late in the review cycle, indicating a disconnect between sponsor expectations and FDA standards. Recent CRLs ...

The US Food and Drug Administration (FDA) recently announced the availability of the first-ever centralized database of Complete Response Letters (CRLs) on openFDA, one of several steps taken under ...

A CRL signifies non-approval of a drug/application in its current form, but allows for issue resolution and potential approval. In 2025, the FDA began publishing CRLs to enhance transparency, ...

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 ...

The FDA has released an "initial batch" of more than 200 complete response letters (CRLs) in efforts to boost transparency. The attempt may have created more questions, however, with only certain ...

In 2024, multiple drugs received complete response letters (CRLs), sometimes unrelated to the safety and efficacy of the drug, but patients with schizophrenia gained the first new treatment with a new ...

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 ...