FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF NEW DRUGS
OFFICE OF DRUG EVALUATION IV
DIVISION OF NONPRESCRIPTION CLINICAL EVALUATION
Effective Date: 01/12/2010
1. DIVISION OF NONPRESCRIPTION CLINICAL EVALUATION (DBNRED).
A. Coordinates and/or reviews and decides on the appropriate action, including approval or disapproval, of all applications for nonprescription drug products, prescription switches to nonprescription status, and other non prescription related products with the exception of new molecular entitles and generic Over-the-Counter (OTC) applications.
B. Develops and implements standards for the safety and effectiveness of nonprescription drug products marketed or to be marketed under approved new drug applications (NDAs).
C. Develops policy and procedures for the review of nonprescription drug products.
D. Develops policy and procedures pertinent to the design and conduct of consumer labeling comprehension and actual use studies and provides review expertise for these studies.
E. Develops policy and procedures pertinent to product development for nonprescription marketing approval.
F. Coordinates Center- wide research activities on nonprescription product issues.
G. Serves as the primary Agency contact for nonprescription drug products marketed or to be marketed under approved NDAs.
H. Solicits and nominates candidates for the Nonprescription Drug Advisory committee (NDAC), and determines what topics are discussed with the NDAC. Initiates actions based on recommendations made by nonprescription advisory panels, public comments and new data received.
I. Participates in consumer and professional education programs on nonprescription drug products.
J. Maintains updated information on nonprescription drug internet and intranet web sites.
K. Interacts with trade groups associated with OTC drug product manufacturers.
L. Provides response to press and Congressional inquiries related to OTC drugs marketed or to be marketed under approved NDAs.
M. Develops guidance documents related to OTC drug products marketed or to be marketed under approved NDAs.
N. Provides scientific review of issues related to the development of OTC drug monographs.
O. Interacts with other groups within Center for Drug Evaluation and Research (CDER) to endure consistent standards of safety and effectiveness with similar prescription products marketed under approved NDAs.
P. Works collaboratively with the Office of Drug Safety to conduct continuing surveillance and medical evaluation of the labeling, clinical experience, and reports submitted by IND sponsors, by NDA applicants, and from other sources.
Q. Develops, in coordination with other Agency components, guidance for staff, sponsors and the public that describes the agency’s interpretation of or policy on regulatory issues that involve the division.
2. AUTHORITY AND EFFECTIVE DATE.
This functional statement was approved by the Commissioner of Food and Drugs on January 12, 2010.
(I, R, C)
OF CHANGE HISTORY
|Acting Director, Center for Drug Evaluation and Research|
|Commissioner of Food and Drugs|