{"abstract":"The Food and Drug Administration (FDA) is amending its regulations on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for approval to market new drugs and generic drugs (drugs for which approval is sought in an ANDA). The final rule discontinues FDA's use of approvable letters and not approvable letters when taking action on marketing applications. Instead, we will send applicants a complete response letter to indicate that the review cycle for an application is complete and that the application is not ready for approval. We are also revising the regulations on extending the review cycle due to the submission of an amendment to an unapproved application and starting a new review cycle after the resubmission of an application following receipt of a complete response letter. In addition, we are adding to the regulations on biologics license applications (BLAs) provisions 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 (PDUFA III) that address procedures and establish target timeframes for reviewing human drug applications.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2008/07/10/E8-15608.html","cfr_references":[{"chapter":null,"citation_url":null,"part":312,"title":21},{"chapter":null,"citation_url":null,"part":314,"title":21},{"chapter":null,"citation_url":null,"part":600,"title":21},{"chapter":null,"citation_url":null,"part":601,"title":21}],"citation":"73 FR 39588","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective August 11, 2008.","disposition_notes":null,"docket_ids":["Docket No. FDA-2004-N-0510"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2025-04-23T12:56:30.185-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2004-N-0510-0002","allow_late_comments":false,"id":"FDA-2004-N-0510-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2004-N-0510","title":"Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications\n\n\n"}],"document_number":"E8-15608","effective_on":"2008-08-11","end_page":39611,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2008/07/10/E8-15608.xml","html_url":"https://www.federalregister.gov/documents/2008/07/10/E8-15608/applications-for-approval-to-market-a-new-drug-complete-response-letter-amendments-to-unapproved","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E8-15608?publication_date=2008-07-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2008-07-10/E8-15608/mods.xml","not_received_for_publication":null,"page_length":24,"page_views":{"count":3670,"last_updated":"2026-07-27 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2008-07-10/pdf/E8-15608.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2008-07-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2008/07/10/E8-15608.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2004-N-0510","supporting_documents_count":0,"docket_id":"FDA-2004-N-0510","document_id":"FDA-2004-N-0510-0002","regulation_id_number":null,"title":"Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications\n\n\n","checked_regulationsdotgov_at":"2025-04-24T15:55:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":39588,"subtype":null,"title":"Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications","toc_doc":"Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications","toc_subject":null,"topics":["Administrative practice and procedure","Biologics","Confidential business information","Drugs","Exports","Imports","Investigations","Labeling","Medical research","Reporting and recordkeeping requirements","Safety"],"type":"Rule","volume":73}