SMG 1262.5

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 COMPLIANCE

OFFICE OF SCIENTIFIC INVESTIGATIONS

Effective Date: 07/08/2011

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1. OFFICE OF SCIENTIFIC INVESTIGATIONS (DKKNDE)

A. Develops policies, surveillance activities, and compliance strategies relating to nonclinical and clinical drug product studies, bioequivalence studies, human subject protections, post-market Adverse Drug Experience reporting requirements, Risk Evaluation and Mitigation Strategies, and commitments for Postmarketing Requirements and Safety Labeling

B. Develops and implements the Agency's Bioresearch Monitoring Program for Human Drugs under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, the Food and Drug Amendments Act, other Federal statutes, and applicable regulations

C. Develops, contributes and formalizes regulatory strategies and guidance including CDER MaPPs, Staff Guidance Manuals, and Compliance Program Guidance Manuals to promote compliance with Good Clinical Practice (GCP) in research, human subject protections, Good Laboratory Practices, Bioequivalence, Pharmacovigilance, Risk Evaluation and Mitigation Strategies, and Safety Labeling

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	10/16/2008	N/a	OC/OO/ OM/OMP	Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research
Revision	05/20/2011	N/a	CDER/OM	Commissioner of Food and Drugs
Revision	07/08/2011	N/a	CDER/OM	Secretary of the Department of Health and Human Services