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U.S. Department of Health and Human Services

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SMG 1264.31

FDA STAFF MANUAL GUIDES, VOLUME I-ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF PHARMACEUTICAL SCIENCE

OFFICE OF GENERIC DRUGS

DIVISION OF BIOEQUIVALENCE I

Effective Date: 05/25/2011

[PDF Version]

1.  DIVISION OF BIOEQUIVALENCE I (DBNSBA).

A. Evaluates in vivo and in vitro bioequivalence data and protocols in Abbreviated New Drug· Applications (ANDAs) and their supplements and amendments.

B. Recommends approval, disapproval, or new bioequivalence studies and/or protocols.

C. Identifies potential bioequivalence problems and provides guidance for conducting bioequivalence studies particularly with respect to hormone containing products, ophthalmic, among other products.

D. Reviews and evaluates drug disposition data and specialized drug delivery systems to assure bioequivalence of drug products.

2.  AUTHORITY AND EFFECTIVE DATE.

The functional statements for this Division were approved by the Secretary of Health and Human Services effective, May 25, 2011.

STATUS
(I, R, C)
DATE APPROVED LOCATION
OF CHANGE HISTORY
CONTACT APPROVING OFFICIAL
Initial 05/25/2011 N/a CDER/OM Secretary of Health and Human Services