FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
OFFICE OF MEDICAL PRODUCTS A
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
OFFICE OF BLOOD RESEARCH AND REVIEW
DIVISION OF HEMATOLOGY
Effective Date: July 8, 2011
1. DIVISION OF HEMATOLOGY (DKKBDB).
A. Reviews, evaluates, and recommends appropriate action on product license applications/biologics license applications (PLAs/BLAs), investigational new drug applications (INDs), new drug applications (NDAs), 510(k) submissions and, as needed, establishment license applications (ELAs) pertinent to the products within the Division's purview.
B. Plans and conducts research related to the development, manufacture, testing, characterization, and actions of certain biological blood products and plasma derivatives as well as research addressing the freedom of such products from chemical and infectious contaminants.
C. Develops and maintains scientific programs dealing with reagent standards used in the testing of regulated products within the purview of the Division.
D. Tests products submitted in support of INDs, license applications and amendments, NDAs and supplements, for release, or for special post-marketing surveillance.
E. Initiates the development of regulatory policies and documents concerning biological blood products.
F. Provides consultation and serves as a source of information within the Center on hemostatic and thrombolytic agents, agents for prophylaxis and treatment of infectious diseases, irradiated blood and blood products, automated plasmapheresis devices for commercial establishments, ELAs and amendments, and on issues related to viral contamination of blood products.
G. Cooperates with other Agency components, PHS agencies, governmental and international agencies, academia, manufacturers, and others on issues related to biological blood products.
H. Acts as product specialists, as part of Team Biologics and as part of inspection team for pre-license review, for inspections of manufacturing facilities for compliance with applicable standards.
I. Evaluates clinical experience and adverse reaction reports relating to products within the Division's responsibility or requiring expertise in hematology.
J. Reviews, evaluates, and identifies potential biolgical warfare threats and methods to protect against these potential threats.
K. Performs the clinical review for OBRR applications which include adherence to regulations relating to clinical trials, safety aspects of applications for investigational and marketing applications, and appropriate trial design to demonstrate efficacy.
2. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this Division were approved by the Secretary of the Department of Health and Human Services on July 8, 2011.