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U.S. Department of Health and Human Services

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Letter from Dr. Michael Friedman, Acting Commissioner of Food and Drugs

Department of HHS

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 Food and Drug Administration

Office of the Commissioner
Rockville, MD 20857


July 1, 1998

Dear Stakeholder,

We at the Food and Drug Administration take great pride in our achievements in implementing the Prescription Drug User Fee Act of 1992 (PDUFA). With the substantial additional resources made available under that Act, significant improvements were made in the drug application review process between 1992 and 1997. During this same period, the agency reduced, by about 40%, the length of time it required to review new drug and biologic license applications, without compromising review soundness and quality.

The Agency received the prestigious Innovations in American Government Award in late 1997 for these achievements. More importantly, Congress recognized these achievements by authorizing PDUFA for five more years, through 2002, as a part of the Food and Drug Administration Modernization Act of 1997. We refer to this amended and extended Act as PDUFA II, and to the original Act as PDUFA I. PDUFA II will provide additional resources over the next five years. Those resources are provided to enable FDA to meet a new set of ambitious goals for both product development and review.

To assure that PDUFA II is at least as successful as PDUFA I, FDA initiated an intensive planning effort, challenging responsible FDA components to map out what they must accomplish over the next five years and what investments they must make each year to meet these demanding new goals. The result is this PDUFA II Five-Year Plan.

In our continuing efforts to maximize the availability and clarity of information about our review processes and plans, we are sharing this plan with all who have an interest and are making it available on the Internet (at "www.fda.gov/oc/pdufa2/5yrplan.html"). Annual adjustments to this plan are envisioned to reflect changing circumstances, including workload and fee revenue adjustments. We welcome comments, and will consider them as future adjustments are made. Comments should be addressed to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852, and should refer to Docket No.98N-0495.


Michael A. Friedman, M.D.
Acting Commissioner of Food and Drugs