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HHS/FDA | RIN: 0910-AI37 | Publication ID: Spring 2022 |
Title: Investigational New Drug Application Annual Reporting | |
Abstract:
This proposed rule, if finalized, would amend FDA’s requirements concerning annual reports submitted by sponsors to investigational new drug applications (INDs) by replacing FDA’s current annual reporting requirement with a new requirement for an FDA development safety update report (FDA DSUR). The proposed FDA DSUR is intended to be consistent with the format and content for IND annual reporting supported by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and is more comprehensive, and informative than the IND annual report currently required by FDA. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: No |
CFR Citation: 21 CFR 312.3 21 CFR 312.33 | |
Legal Authority: 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 353 21 U.S.C. 355(i) 21 U.S.C. 371(a) 42 U.S.C. 262 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Dat Doan Supervisory Regulatory Health Project Manager Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, WO 51, Room 3334, Silver Spring, MD 20993 Phone:240 402-8926 Email: dat.doan@fda.hhs.gov |