United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2008_register executive 2010-09-23 article Rules and Regulations D09002ee1c80886a9 D09002ee1c8088737 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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. 73 FR 39588 https://www.govinfo.gov/app/details/FR-2008-07-10/E8-15608 E8-15608 fr10jy08-11 4160-01-S Docket No. FDA-2004-N-0510 https://www.govinfo.gov/app/details/FR-2008-07-10/E8-15608 https://www.govinfo.gov/content/pkg/FR-2008-07-10/html/E8-15608.htm https://www.govinfo.gov/content/pkg/FR-2008-07-10/pdf/E8-15608.pdf Drugs Exports Imports Investigations Labeling Medical Research Reporting and Recordkeeping Requirements Safety Administrative Practice and Procedure Confidential Business Information Biologics 24 p. 39588 39611 73 FR 39588 Title 21 Part 312 21 CFR Part 312 Title 21 Part 314 21 CFR Part 314 Title 21 Part 600 21 CFR Part 600 Title 21 Part 601 21 CFR Part 601 Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications; Federal Register Vol. 73, Issue RULE E8-15608 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2008-08-11 Docket No. FDA-2004-N-0510 4160-01-S E8-15608 Final rule.

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.

This rule is effective August 11, 2008. Brian L. Pendleton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6304, Silver Spring, MD 20993, 301-796- 3504; or Drugs Exports Imports Investigations Labeling Medical Research Reporting and Recordkeeping Requirements Safety Administrative Practice and Procedure Confidential Business Information Biologics Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications, Vol. 73, no. 133 Office of the Federal Register, National Archives and Records Administration 2008-07-10 continuing daily deposited born digital 298 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2008-07-10 P0b002ee1809b7fd7 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr10jy08 https://www.govinfo.gov/app/details/FR-2008-07-10 https://www.govinfo.gov/content/pkg/FR-2008-07-10/pdf/FR-2008-07-10.pdf https://www.govinfo.gov/content/pkg/FR-2008-07-10/xml/FR-2008-07-10.xml fdlp 39569 39855 DGPO 2010-09-23 2024-06-05 FR-2008-07-10 machine generated eng FR FR-2008-07-10 73 133