Complete Response letter (CRL)
Important Facts to Remember…….
· Complete response letters will only be issued for applications that are not approved (A Complete Response Letter informs companies that an application is not ready for approval).
· A complete response letter (CRL) from the FDA delays a product’s entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them.
· With limited exceptions, the public does not receive a full account of the FDA’s reasons for disapproval because complete response letters are part of unapproved applications that FDA regulations generally treat as confidential.
· CRL is designed to help reduce the number of ANDA review cycles, which has significantly decreased the efficiency of the ANDA review and approval process.
· Agency's Center for Drug Evaluation and Research (CDER) issues the CRL at the end of review process.