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U.S. Department of Health and Human Services

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SMG 1260.2

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 REGULATORY POLICY

Effective Date: 07/08/2011

[PDF Version]

1. OFFICE OF REGULATORY POLICY (DKKNAA)

A.Provides Center oversight and leadership in the development of regulations, policies, procedures and guidance's that affect the drug approval process, and in the development of new legislation

B.Provides Center oversight and leadership in the administration of the user fee billing and waiver program, and patent extensions

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 APPROVEDLOCATION
OF CHANGE HISTORY		CONTACTAPPROVING OFFICIAL
Initial07/08/2011N/aCDER/OMSecretary of the Department
of Health and Human Services

 

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