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SMG 1264.40

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF PHARMACEUTICAL SCIENCE

OFFICE OF NEW DRUG QUALITY ASSESSMENT

Effective Date: 01/12/2010

[PDF Version]

1. OFFICE OF NEW DRUG QUALITY ASSESSMENT (DBNSC).

A. Manages scientific issues and evaluation of critical pharmaceutical quality attributes and their relevance to safety and efficacy and ensures consistency in new drug quality assessments/chemistry reviews.

B. Manages the overall coordination for IND and NDA pharmaceutical quality review processes within the Office.

C. Reviews and evaluates the chemistry and product quality portion of INDs, NDAs, amendments, and supplements for drugs regulated by this Office and recommends appropriate action with respect to safety.

D. Evaluates chemistry, formulation, manufacturing processes, dosage forms, dissolution / release rate, product performance, and facilities of manufacturers of drugs submitted for approval in NDAs for drugs regulated by the Office.

E. Develops policy and procedures governing the pharmaceutical quality assessment /chemistry review and evaluation of INDs and NDAs, including regulatory policies for cross-cutting CMC issues.

F. Provides advice and information to other components of the Center and the Agency on quality assessment of pharmaceutical formulation, manufacturing processes, and product performance issues as they relate to human drugs regulated by the Center.

G. Facilitates new drug development.

2. AUTHORITY AND EFFECTIVE DATE.

This functional statement was approved by the Commissioner of Food and Drugs on January 12, 2010.

STATUS
(I, R, C)
DATE APPROVEDLOCATION
OF CHANGE HISTORY
CONTACTAPPROVING OFFICIAL
Initial01/12/2010N/aOC/OA/
OM/OMP
Commissioner of Food and Drugs