Pledging ‘Radical Transparency,’ FDA Reveals Drug Rejection Letters — With Limits

Pledging ‘Radical Transparency,’ FDA Reveals Drug Rejection Letters — With Limits

The FDA published more than 200 complete response letters, the first step in what it describes as part of its effort to modernize the agency and improve transparency. But there are some caveats to the release of the FDA correspondence. The post Pledging ‘Radical Transparency,’ FDA Reveals Drug Rejection Letters — With Limits appeared first on MedCity News.

Ultragenyx receives complete response letter for UX111 BLA

Ultragenyx Pharmaceutical has received a complete response letter (CRL) from the FDA concerning its BLA for UX111 (ABO-102).

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 (CRLs) issued between 2020 and 2024. These decision letters, historically kept confidential, detail the reasons the agency declined to approve certain drug and biological product applications in their original form. CRLs are formal communications sent t…

Pledging ‘Radical Transparency,’ FDA Reveals Drug Rejection Letters — With Limits – RamaOnHealthcare

The FDA published more than 200 complete response letters, the first step in what it describes as part of its effort to modernize the agency and improve