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CDER 2007 Update
User Fee Program
Americans deserve timely access to potentially lifesaving new drugs as soon as possible once they are proven safe and effective. The Prescription Drug User Fee Act of 1992 received its second five-year extension in 2002, known as PDUFA III. This reauthorization helps us ensure that we have the staff and resources to review applications promptly, and get safe, effective new drugs into the hands of the people who need them. The reauthorization also allows user fees to support some safety activities, both during development and for newly approved medicines. The current user fee law maintains our high review performance goals, includes increased consultations with drug sponsors and provides for earlier feedback on their submissions.
User fee performance
Under legislation authorizing us to collect user fees for drug reviews, we agreed to specific performance goals for the prompt review of submissions.
- We met or exceeded almost all our performance goals for the fiscal year 2006 receipts.
- We are on track to meet or exceed most user-fee performance goals for the fiscal year 2007.
Continuous marketing application pilot programs
Under PDUFA III, we are assessing the value of both early review of parts of marketing applications and of more extensive feedback to sponsors during their development programs. Two pilots for continuous marketing applications apply to drugs and biologics in our fast track program:
- Pilot 1 allows applicants to submit predefined portions of their marketing applications called reviewable units before submitting the completed application. Each reviewable unit has a six-month goal for issuing a discipline review letter. In 2007, we did not meet our performance goal for reviewable unit submissions.
- Pilot 2 allows us to enter into agreements with sponsors for frequent scientific feedback and interactions during the clinical trial phase of product development. As of Sept. 30, 2007, there were nine development projects entered in the Pilot 2 program.
More information is available at www.fda.gov/cder/pdufa/CMA.htm.
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Date created: July 31, 2008 |
