CRLs Are the Low-Hanging Fruit of FDA Transparency, Experts Say

Why FDA’s CRL release could open the door to lawsuits against pharma

In a push for “radical transparency” the FDA released 200 CRLs for drugs that were later approved — some of which are now public for the first time.

CRLs Are the Low-Hanging Fruit of FDA Transparency, Experts Say

(MedPage Today) -- 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 agency has bigger transparency...

FDA: FDA Embraces Radical Transparency by Publishing Complete Response Letters | ResearchBuzz: Firehose

FDA: FDA Embraces Radical Transparency by Publishing Complete Response Letters. “The U.S. Food and Drug Administration (FDA) today published more than 200 decision letters, known as complete response letters (CRLs). The CRLs were issued in response to applications submitted to the FDA for approval of drugs or biological products between 2020 and 2024, marking a significant step in the Agency’s broader initiatives to modernize and increase transp…