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SMG 1263.50

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF MEDICAL PRODUCTS AND TOBACCO

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF NEW DRUGS

OFFICE OF ANTIMICROBIAL PRODUCTS

Effective Date: 07/08/2011

[PDF Version]

1. OFFICE OF ANTIMICROBIAL PRODUCTS (DKKNRD)

A. Reviews notices of claimed investigational exemptions for new drugs (INDs) within classes of drugs regulated by the Office and recommends appropriate action with respect to safety and effectiveness of clinical trials

B. Evaluates for safety and effectiveness and approves new drug applications (NDAs) for products regulated by the Office, and evaluates supplements that propose changes in the conditions upon which NDA approvals are based

C. Develops policy and procedures governing the review and evaluation of drug investigations and NDAs

D. Evaluates and takes appropriate action on recommendations concerning withdrawal of approval for NDAs for products regulated by the Office

E. Performs consulting medical and scientific evaluations of submission on generic drugs, drugs under monograph, and over-the-counter drug products regulated by other offices in the Center

F. Works collaboratively with the Office of Drug Safety to conducts continuing surveillance and medical evaluation of labeling, clinical experience, and reports submitted by IND sponsors, NDA applicants, and other sources

G. Provides advice and information to other components of the Center, Agency, Department and other relevant parties on issues related to bioterrorism and emerging infections

H. Coordinates activities within the Center related to antimicrobial resistance. Provides advice to other components of the Agency, Department and other relevant parties on issues related to antibiotic resistance

I. Coordinates activities, provides advice and information related to drug shortage activities to other components of the Center, Agency and the Department

J. 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 Office of Drug Evaluation (ODE)

2. AUTHORITY AND EFFECTIVE DATE

The functional statements for this Office were approved by the Secretary of the Department of Health and Human Services on July 8, 2011.

STATUS
(I, R, C)
DATE APPROVED LOCATION
OF CHANGE HISTORY
CONTACT APPROVING OFFICIAL
Initial 05/01/2005 N/a OC/OO/
OM/OMP
Acting Director, Center for Drug Evaluation and Research
Revision 07/08/2011 N/a CDER/OM Secretary of the Department
of Health and Human Services