Database of FDA Rejection Letters Adds Transparency to Biosimilar Development

The FDA released today a database of complete response letters (CRLs) sent to manufacturers of small molecule and biologic drug candidates that were eventually approved for marketing in the US between 2020 and 2024. This transparency opens a window to  information that is not always publicized by the sponsoring manufacturer. Sometimes, CRLs are announced by … Continue reading Database of FDA Rejection Letters Adds Transparency to Biosimilar Development