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
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.
(I, R, C)
OF CHANGE HISTORY
|Initial||05/25/2011||N/a||CDER/OM||Secretary of Health and Human Services|