Prescription Drug User Fee

The Prescription Drug User Fee Act allows the FDA to charge fees in order to hire more staff to speed up the review process and thus deliver faster approval decisions. 

Prescription Drug Marketing Act, 18 686 Prescription drugs, 21 575 Prescription Drug User Fee Act, 78 686 Presedimentation reservoir, in water treatment, 26 103... 

Safe Medical Device Amendments, requiring more extensive testing of devices. 1992 Prescription Drug User Fee Act. Established the payment of fees for the filing of applications (e.g., IND, NDA, PLA, etc.)... 

Based on the Prescription Drug User Fee Act (PDUFA), the FDA collects fees from applicants to expedite the review and approval processes under strict guidelines. Tlie PDUFA fees for fiscal year 2007 (October 1,2006 to September 30,2007) are shown in Table 8.2. 

Source Food and Drug Administration. Prescription Drug User Fee Rates for Fiscal Year 2007. http //www.fda,gov/ohrms/dockets/98fr/E6-12397.pdf [accessed September 12,2007]. 

PDUFA Prescription Drug User Fee Act (United States)... 

Reauthoiises prescription drug user fees for another 5 years. 

Prescription Drug User Fee Act (PDUFA) (1992). In this law, manufacturers agreed to pay user fees for certain new drug applications and supplements, an annual establishment fee, and annual product fees. Using these funds, FDA can hire... 

Rettig, R. A., The Implementation of the Prescription Drug User Fee Act of1992 by the Food and Drug Administration, RAND, unpublished document. 

Under the Prescription Drug User Fee Act, the FDA can levy fees for the review of applications containing clinical trial data, although waivers can be sought for nonprofit sponsors and small businesses. 

Congress passes the Prescription Drug User Fee Act, which requires the pharmaceutical industry to pay user fees to the FDA in return for faster approval time. With the funds, the FDA will hire new workers for the Center for Drug Evaluation and Research and the Center for Biologies Evaluation Research. 

The FDA Modernization Act reauthorizes the Prescription Drug User Fee Act and the system of having drug companies subsidize reviews of... 

When an NDA comes in, the FDA has 60 days to decide whether to file it so that it can be reviewed. The FDA can refuse to file an application that is incomplete. For example, some required studies may be missing. In accordance with the Prescription Drug User Fee Act (PDUFA), the FDA s Center for Drug Evaluation and Research (CDER) expects to review and act on at least 90 percent of NDAs for standard drugs no later than 10 months after the applications are received. The review goal is six months for priority drugs. (See The Role of User Fees. )... 

Prescription Drug User Fee Act (1992) Reauthorized 1997 and 2002. Manufacturers pay user fees for certain new drug applications. FDA claims review time for new chemical entities dropped from 30 months in 1992 to 20 months in 1994. 

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