Performance Improvement 2000. Drug Application Review


Establishing Mechanisms for Meeting Review Time Periods Specified in the Food, Drug, and Cosmetic Act

This report was prepared in response to Section 406(b) of the Food and Drug Modernization Act of 1997 (FDAMA) which stipulates that by July 1, 1999, FDA establish mechanisms for meeting review times for applications and submissions as specified in its enabling legislation. The report summarizes a listing of 110 mechanisms as of July 1, 1999 that were ascertained from FDA documents. These mechanisms were developed within the context of six strategic directions set forth in the FDA Plan for Statutory Compliance-November 1998, representing a combination of approaches that have reached a focal point as a result of FDAMA.

AGENCY SPONSOR: Office of Planning, Policy & Legislation


PIC ID: 7273

PERFORMER: Office of Policy, Planning, and Legislation, FDA
Rockville MD

Office of New Drug Chemistry: Annual Report of Statistical Data

Workload and accomplishments data for investigational new drug applications and new drug applications for fiscal year 1998 is compiled by the Office of New Drug Chemistry of the FDA's Office of Pharmaceutical Science on an annual basis and reported in this publication. Data include the number of submissions received, by type and quantity; trends in rate of original receipts; forecasts of workload for the next fiscal year with possible personnel requirements; adherence to schedules; and analysis of completed reviews.

AGENCY SPONSOR: Center for Drug Evaluation and Research


PIC ID: 7274

PERFORMER: Food and Drug Administration
Rockville, MD