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HHS/FDA | RIN: 0910-AC23 | Publication ID: Fall 2006 |
Title: Requirements for Submission of In Vivo Bioequivalence Data | |
Abstract: The Food and Drug Administration (FDA) is proposing to amend its regulations on submission of bioequivalence (BE) data to require an abbreviated new drug application (ANDA) applicant to submit data from all BE studies the applicant conducts on a drug product formulation submitted for approval. In the past, ANDA applicants have submitted BE studies demonstrating that a generic product meets BE criteria for FDA to approve the ANDA but have not typically submitted additional BE studies conducted on the same drug product formulation. FDA is proposing to require ANDA applicants to submit information, in either a complete or summary report, from all additional passing and nonpassing BE studies conducted on the same drug product formulation submitted for approval. | |
Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Long-Term Actions |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 314.96(a)(1) 21 CFR 314.94(a)(7) 21 CFR 320.21(b)(1) | |
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 355a 21 USC 356 21 USC 356a to 356c 21 USC 371 21 USC 374 21 USC 379 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
Agency Contact: Christine F. Rogers Regulatory Counsel Department of Health and Human Services Food and Drug Administration HFD-7, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Bldg. 51, Room 6304, Silver Spring, MD 20993-0002 Phone:301 796-3601 Fax:301 847-8440 |