Yesterday the Clinical Decision Support (CDS) Coalition released a comment broadly criticizing the FDA’s recent CDS draft guidance, noting that the draft would expand the scope of FDA regulations, and ...
The goal is to improve public understanding of the FDA decision-making process. (HealthDay News) — The U.S. Food and Drug Administration has published more than 200 complete response letters, or ...
A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and ...
WASHINGTON, Jan. 8, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has received a decision letter from the U.S. Food and Drug Administration's (FDA) ...
The U.S. Food and Drug Administration said it will begin publishing rejection letters sent to drugmakers in real time as part of the agency's push for increased transparency. The FDA on Thursday said ...
The next time the FDA turns down a drug application, the letter outlining the decision and the regulator’s reasoning will become public record. The agency said it will release future complete response ...
Hosted on MSN
FDA Publishes Over 200 Complete Response Letters to Increase Drug Approval Transparency
WASHINGTON, D.C. — In a landmark move to improve transparency and modernize regulatory processes, the U.S. Food and Drug Administration (FDA) has published more than 200 complete response letters ...
On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced that it was embracing “radical transparency” by publishing more than 200 Complete Response Letters (CRLs) — letters the agency ...
Results that may be inaccessible to you are currently showing.
Hide inaccessible results
Feedback