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U.S. Department of Health and Human Services

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SMG 1263.60

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 DRUG EVALUATION IV

Effective Date: 07/08/2011

[PDF Version]

1. OFFICE OF DRUG EVALUATION IV (DKKNRE)

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

B. Evaluates the safety and effectiveness and approves new drug applications (NDAs) for products regulated by this Office, including nonprescription products and medical imaging products

C. Evaluates the safety and effectiveness and approves NDA supplements that propose changes in the conditions upon which NDA approvals are based for products regulated by this Office, including nonprescription products and medical imaging products

D. Evaluates the safety and effectiveness of drugs regulated under the OTC Drug Review and develops the associated regulations

E. Oversees the development of policy and procedures governing the review and evaluation of nonprescription products

F. Oversees the development of policy and procedures governing the review and evaluation of imaging products

G. Oversees the development of policy and procedures governing the review and evaluation of reports submitted to the radioactive drugs research committee (RDRC) program

H. Performs medical consultations and scientific evaluations of submissions from other offices in CDER or other Centers within FDA

I. 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)

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

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.

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 01/12/2010 N/a OC/OA/
OM/OMP		 Commissioner of Food and Drugs
Revision 07/08/2011 N/a CDER/OM Secretary of the Department
of Health and Human Services

 

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