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HHS/FDA | RIN: 0910-AB34 | Publication ID: Spring 2007 |
Title: Applications for FDA Approval To Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications | |
Abstract: The rule would amend the regulations on marketing approval of new drugs to discontinue the use of approvable and not approvable letters when taking action on a marketing application and instead use complete response letters. The rule would also amend the regulations on extension of the review clock because of amendments to applications. | |
Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: Undetermined | Unfunded Mandates: No |
CFR Citation: 21 CFR 312 21 CFR 314 | |
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 371 21 USC 374 21 USC 379e |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
Agency Contact: Brian L. Pendleton Senior Policy Advisor Department of Health and Human Services Food and Drug Administration Suite 3037 (HFD-7), Office of Policy, WO 32, Room 4250, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone:301 796-4614 Fax:301 847-3541 Email: brian.pendleton@fda.hhs.gov |