SMG 1262.44

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 MANUFACTURING AND PRODUCT QUALITY

DIVISION OF POLICY, COLLABORATION AND DATA OPERATIONS

Effective Date: 07/08/2011

[PDF Version]

1. DIVISION OF POLICY, COLLABORATION AND DATA OPERATIONS (DKKNDAC)

A. Coordinates and develops science and risk-based policy and standards, industry guidance and compliance policy for enforcement of the Federal Food, Drug, and Cosmetic Act as it pertains to drug product quality

B. Develops collaborative approaches with international regulatory partners that allow for leveraging inspectional information and convergence of policies

C. Coordinates Office-field relations and provides support, training, and technical assistance to field offices on case development and regulatory actions; ensures uniform interpretation of scientific standards

D. Leverages data and information on manufacturing and product quality trends to develop policies and compliance strategies

E. Identifies retrospective and prospective drug quality research that will promote increased product quality through application of current good manufacturing practice requirements

2. DRUG SURVEILLANCE AND DATA REPORTING BRANCH (DKKNDAC1)

A. Monitors the quality of the nation's drug supply through post-market surveillance, including the drug sampling program and various others sources of drug quality reports

B. Applies expertise with Agency databases, including Drug Quality Reporting and New Drug Application (NDA) Field Alert System, Establishment Evaluation System, and drug survey data

C. Creates information systems solutions that consolidate data and promptly identify patterns across product, process or facility types

D. Prepares operations and accomplishment reports

E. Collaborate with other Agency offices and divisions on researching and addressing emerging drug product quality trends

3. REGULATORY POLICY AND COMMUNICATIONS BRANCH (DKKNDAC2)

A. Develops manufacturing guidance to promote compliance with drug good manufacturing practice requirements for non-application, drug application and licensing application products

B. Develops internal and external educational programs to promote understanding of drug quality standards, regulatory expectations, and to communicate and receive feedback on emerging policies

C. Develops compliance policy for enforcement of the Federal Food, Drug, and Cosmetic Act regarding drug product quality and adulteration

D. Provides decisions on novel or precedent-setting policy issues

E. Collaborates with ORA in development of drug quality work plan, and monitoring progress

F. Develops strategic partnerships with foreign regulatory health authorities

G. Coordinates or provides technical expertise to foreign governments for harmonization of requirements and program efficiencies for assuring human drug quality in support of harmonized Good Manufacturing Practice (GMP) standards and quality systems

4. 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	05/20/2011	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