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 BIOTECHNOLOGY PRODUCTS
Effective Date: 10/01/2003
1. OFFICE OF BIOTECHNOLOGY PRODUCTS (DBNSE).
A. Plans and conducts research related to the development, manufacture, testing, and activities of therapeutic biological products, including those related to AIDS and those prepared by genetic engineering and synthetic procedures, in order to develop and maintain a scientific base for establishing standards designed to ensure the continued safety, purity, potency, and effectiveness of biological therapeutic products.
B. Performs functions regarding cytokines and analogous products, growth factors (including hematopoietic factors), thrombolytic products, enzymes, monoclonal antibodies and analogous products.
C. Develops policy and procedures governing the pre-market approval review and evaluation of biological therapeutic products in keeping with the provisions of the Public Health Service (PHS) Act and applicable provisions of the Federal Food Drug &Cosmetic (FFD&C) Act.
D. Reviews, evaluates and takes appropriate action on investigational new drug applications (INDs) related to therapeutic products and amendments or supplements to these applications. Actions include, but are not limited to, approval or disapproval of research plans and protocols, modifications, and restrictions.
E. Performs the investigational device exemption (IDE) review process for devices related to biological therapeutic products regulated the Office, and develops related policy.
F. Performs the investigational device exemption (IDE) review process for devices related to biological therapeutic products regulated the Office, and develops related policy.
G. In cooperation with other Center components, as appropriate, tests products submitted for release by manufacturers.
H. Participates in inspections of manufacturing facilities for compliance with applicable standards.
I. Reviews, evaluates, and takes appropriate action on recommendations concerning denial of license applications for products.
J. Administers applicable provisions of the FFD&C Act as they pertain to certain devices and drugs that are under the jurisdiction of the Office.
K. Cooperates with other Agency components and outside organizations on a variety of issues related to these products.
2. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this Office were approved by the Commissioner, Food and Drug Administration effective October 1, 2003.