Performance Improvement 1999. Crosscutting

02/01/1999

TITLE: Real-Time PMA Supplement Program Evaluation

ABSTRACT: The Office of Device Evaluation (ODE), Food and Drug Administration (FDA) is implementing the "Real-Time" program for pre-market application (PMA).

AGENCY SPONSOR: Center for Devices and Radiological Health

FEDERAL CONTACT: Maryann Munson

PHONE NUMBER: 301-594-1284

PIC ID: 6732

PERFORMER ORGANIZATION: Office of Systems and Management, FDA, Rockville, MD

PROJECTED DATE OF COMPLETION: 9/30/00
 

TITLE: Laboratory Support Services for FDA Compliance and Surveillance

ABSTRACT: This initiative of the human drug program involves multiple evaluative aspects. Two examples are: (1) conducting the hormones surveillance program, and (2) developing analytical methods for drug fingerprinting in the assessment of drug quality. The anticipated outcome of this effort will support the Food and Drug Administration's (FDA's) regulatory actions by providing laboratory support for the agency's compliance and methods development functions. In addition, drug fingerprint profiles will provide forensic assessments of drug manufacturing origin in support of FDA investigational efforts in deterring drug counterfeiting.

AGENCY SPONSOR: Center for Drug Evaluation and Research

FEDERAL CONTACT: Joe Hanig

PHONE NUMBER: 301-594-5026

PIC ID: 7107

PERFORMER ORGANIZATION: Center for Drug Evaluation and Research, FDA, Rockville MD

PROJECTED DATE OF COMPLETION: 9/30/00