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HHS/FDA RIN: 0910-AC23 Publication ID: Spring 2008 
Title: Requirements for Submission of In Vivo Bioequivalence Data 
Abstract: The Food and Drug Administration (FDA) published a proposed regulation on October 29, 2003 (68 FR 61640), that would 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. If finalized, this rule would 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 
RIN Data Printed in the FR: Yes 
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

 
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