In an unprecedented move, the FDA has released an initial batch of over 200 complete response letters (CRLs) issued from 2020 to 2024, offering insight into deficiencies cited in drug approval applications. These publicly disclosed documents, mostly redacted for confidentiality, correspond to products that were later approved. The agency aims to bolster transparency surrounding its decision-making and common approval hurdles. The FDA stresses that release of CRLs can help drug developers, investors, and the public better understand regulatory expectations and reduce uncertainty in drug development.