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 CLINICAL REVIEW
Effective Date: 05/25/2011
1. DIVISION OF CLINICAL REVIEW (DBNSBG).
A. Evaluates bioequivalence studies with clinical endpoints and protocols supporting Abbreviated New Drug Applications (ANDAs) and supplements to ANDAs.
B. Recommends approval, disapproval, or new bioequivalence with clinical endpoints and/or protocols.
C. Identifies potential clinical safety or product use issues or bioequivalence problems and provides guidance for resolving the matters.
D. Reviews and evaluates drug disposition data and specialized drug delivery systems to assure bioequivalence of generic drug products.
2. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this Division were approved by the Secretary of Health and Human Services on 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|