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HHS/FDA

RIN: 0910-AC23

Publication ID: Spring 2007

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

Timetable:

Action	Date	FR Cite
NPRM	10/29/2003	68 FR 61640
Final Action	To Be Determined

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