SMG 1114.10

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF THE COMMISSIONER

OFFICE OF THE CHIEF SCIENTIST

OFFICE OF SPECIAL HEALTH ISSUES

Effective Date: 01/13/2009

1. OFFICE OF SPECIAL HEALTH ISSUES (DAED).

A. Serves as an information resource to FDA and provides advice to the Commissioner and other key agency officials on matters related to serious and life-threatening diseases; patient, patient advocacy, and health professional organizations; minority health and other special health issues.

B. Coordinates interactions between FDA and health professional organizations and patient advocacy groups dealing with serious and life-threatening diseases and other special health issues.

C. Serves as a focal point to coordinate contacts between FDA and other federal agencies to ensure effective coordination and communication on serious and life-threatening diseases and other special health issues.

D. Provides internal coordination on FDA activities related to serious and life-threatening diseases, patient advocacy and health professional organizations, and other special health issues.

E. Assists in the planning, administration, development, and evaluation of FDA policies related to serious and life-threatening diseases, patient advocacy and health professional organizations, and other special health issues.

2. MEDWATCH STAFF (DAED1).

A. Coordinates and implements policies and initiatives relating to human medical product adverse events, including the MedWatch Partners Program, the MedWatch website, and the MedWatch e-list.

B. Conducts outreach and education to health professionals, patients and the public to facilitate the reporting of serious harm and injury associated with the use of human medical products.

C. Reviews, updates, and disseminates medical product safety alerts and safety labeling changes.

3. AUTHORITY AND EFFECTIVE DATE.

The functional statements for this Office were approved by the Commissioner, Food and Drug Administration, effective January 13, 2009.

STATUS (I, R, C)	DATE APPROVED	LOCATION OF CHANGE HISTORY	CONTACT	APPROVING OFFICIAL
Initial	01/13/2009	N/a	OC/OO/OM/OMP	Commissioner of the Food and Drug Administration