CRL (Complete Response Letter)

A Complete Response Letter (CRL) is an official communication from the FDA to a drug sponsor indicating that their application for approval has not yet met all necessary requirements. It outlines specific deficiencies or issues identified during the review process. The sponsor can address these concerns and resubmit the application for further consideration. Essentially, a CRL signals that the approval is not granted at this stage but provides guidance for the steps needed to move forward toward eventual approval.