Performance Improvement 1999. Drug Application Review


TITLE: FY 1998 PDUFA Performance Report

ABSTRACT: In FY 1998, the Food and Drug Administration exceeded all performance goals specified under the Prescription Drug User Fee Act of 1992 (PDUFA). The Agency made its review decisions for drug and biological product submissions on time in almost every case, reviewing 100 percent of the new product applications and 99 percent of the supplements within target review times. By historic standards, approval rates remain high and review times and total approval times remain short. The Food and Drug Administration Modernization Act of 1997 (FDAMA) continues the progression toward quicker reviews begun under PDUFA, and extends into the investigative phase of drug development with a series of new goals that take effect in FY 99. The objective of the FDAMA goals is to speed up the entire drug development process, from research to approval, without compromising safety or sacrificing quality of the application review process.

AGENCY SPONSOR: Office of Planning and Evaluation


PHONE NUMBER: 301-827-5255

PIC ID: 6079.3

PERFORMER ORGANIZATION: Office of Planning and Evaluation, FDA Rockville MD 20857

TITLE: Pharmaceutical Industry Cost Savings Through Use of the Scale-up and Post-Approval Change Guidance for Immediate Release Solid Oral Dosage Forms (SUPAC-IR)

ABSTRACT: The purpose of this study was to determine the impact on, and cost savings to, industry resulting from the Immediate Release Solid Oral Dosage Forms (SUPAC-IR) guidance. Representatives of six pharmaceutical firms were interviewed to ascertain their experiences with the SUPAC-IR program. The survey showed that positive results were achieved because the Food and Drug Administration (FDA) had established a uniform policy for post-approval chemistry and manufacturing and control changes that brought clarity to the regulatory requirements. All of those interviewed thought that the greatest impact of the SUPAC-IR program was the enhancement of industry's ability to plan, implement change, and manage its resources efficiently.

AGENCY SPONSOR: Office of Planning and Evaluation


PHONE NUMBER: 301-827-5335

PIC ID: 7059

PERFORMER ORGANIZATION: Eastern Research Group, Inc. Chantilly, VA