Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications

Resumo

The Food and Drug Administration (FDA) is proposing to amend our regulations on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for approval to market new drugs and generic drugs. We propose to discontinue the use of approvable letters and not approvable letters when taking action on marketing applications. Instead, we intend to use complete response letters to indicate that the review cycle is complete and that the application is not ready for approval. We also are proposing to revise the regulations on extending the review cycle due to the submission of an amendment to an unapproved application and starting a new cycle after a resubmission following receipt of a complete response letter. In addition, we are proposing to add to the regulations on biologics license applications (BLAs) a provision on the issuance of complete response letters to BLA applicants. We are taking these actions to implement the user fee performance goals referenced in the Prescription Drug User Fee Amendments of 2002 that address procedures and establish target timeframes for reviewing human drug applications.