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SMG 1264.1

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF PHARMACEUTICAL SCIENCE

Effective Date: 03/14/2005

[PDF Version]

 1. Office of Pharmaceutical Science
 2. Program Activities Review Staff
 3. Operations Staff
 4. Science and Research Staff
 5. New Drug Microbiology Staff
 6. Authority and Effective Date

1. OFFICE OF PHARMACEUTICAL SCIENCE (DBNS) 

A. Provides scientific and technical advice and information to other components of the Center and Agency on pharmaceutical product quality programs and issues.

B. Develops policies for product quality regulation which describe the level of scientific knowledge supporting product applications, process validation and process capabilities.

C. Oversees laboratory research that supports the development of scientific standards and policies on the composition, quality, safety, and effectiveness of human drug products including biotechnology drug products, and to provide expert advice based on that research in support of the drug review regulatory process.

D. Oversees the scientific review and evaluation of Abbreviated New Drug Applications (ANDAs), and their amendments or supplements for generic drug products, and determines approvability of such products, including developing standards for safety and effectiveness of generic drugs.

E. Oversees the scientific review and evaluation of product quality information in INDs, NDAs, and BLAs, relating to therapeutic products, and insures the consistency of reviews and manages the overall coordination of issues effecting the product quality regulatory process.

F. Oversees the review and evaluation of bioavailability, and bioequivalence protocols and data in INDs, NDAs, and BLAs, relating to therapeutic products, and their supplements and amendments.

G. Administers advisory committee of expert scientists to ensure strong scientific and technical understanding in support of regulatory framework for product quality.

2. PROGRAM ACTIVITIES REVIEW STAFF (DBNS-1) 

A. Participates on Center and Agency activities which ensure effective regulation of product quality for pharmaceutical products including such initiatives as the Product Quality Initiative for the 21st Century and coordinates such activities across all organizational components of the Office of Pharmaceutical Science (OPS).

B. Provides liaison on outside collaborations (e.g., PQRI) as well as international harmonization activities, (e.g. ICH).

C. Provides insight and support for risk management relating to product quality review to ensure appropriate regulatory scrutiny.

D. Develops and supports appropriate product quality policy and guidance across various organization components of OPS.

E. Provides program management support for OPS coordinating committees and other specialty working groups and manages and coordinates the Advisory Committee for Pharmaceutical Science.

F. Provides compendial operations support.

G. Ensures appropriate education and training courses available to promote and support product quality activities.

3. OPERATIONS STAFF (DBNS-2) 

A. Advises the Deputy Director of OPS on all administrative management matters relating to the day-to-day activities of the Office.

B. Provides direct administrative support to the Office in the areas of financial and personnel management and management consulting and office services.

C. Plans and develops management policies and programs which support operations of all Office components.

D. Develops and conducts evaluation studies to determine the effectiveness of Center and Office programs, policies, and priorities and to forecast workloads to determine resource allocations and select alternative operating plans. Proposes improvements in program effectiveness and efficiency.

E. Monitors workflow to determine that program goals and objectives are met.

4. SCIENCE AND RESEARCH STAFF (DBNS-3) 

A. Manages the Therapeutic Inequivalence Action Coordination Committee, which has responsibility for investigating questions of therapeutic inequivalence of pharmaceutical products.

B. Directs the Rapid Response Team, which is responsible for overseeing scientific research that is focused on specific regulatory questions to ensure sound regulatory decision-making.

C. Provides other support to research including doing literature searches and providing scientific input to complicated regulatory cross-cutting issues.

D. Provides project management support, advice and assistance on research done on contracts.

E. Ensures external research activities meet Agency requirements.

F. Ensures appropriate scientific databases are created and supported and facilitates the review process by making better use of accumulated scientific knowledge.

G. Provides clinical information to support scientific decision-making as well as support for informatics and computational analysis.

H. Provides support and scientific direction on new and complex scientific issues.

5. NEW DRUG MICROBIOLOGY STAFF (DBNS-4) 

A. Performs assessments of microbiological sections of new drug manufacturing.

B. Advises Center for Drug Evaluation and Research (CDER) and other centers on applied microbiological issues relating to product quality of new drug manufacturing.

C. Develops appropriate policies and standards as necessary to ensure product quality consistency in review of microbiological products.

6. AUTHORITY AND EFFECTIVE DATE 

A. Office Level. The functional statements for this Office were approved by the Acting Director, Center for Drug Evaluation and Research, effective March 14, 2005.

B. Staff Level. The functional statements for the Program Activities Review Staff, the Operations Staff, the Science and Research Staff, and the New Drug Microbiology Staff were approved by the Acting Director, Center for Drug Evaluation and Research effective March 14, 2005.

STATUS
(I, R, C)
DATE APPROVEDLOCATION
OF CHANGE HISTORY
CONTACTAPPROVING OFFICIAL
Initial03/14/2005N/aOC/OO/
OM/OMP
Acting Director, Center for Drug Evaluation and Research