User fees

In the United States, through the NDA review process, pharmaceutical companies that seek FDA approval for new dmg products are assessed user fees by FDA to gain faster approval, by virtue of the U.S. Prescription Dmg User Fee Act of 1992. These assessments are used to increase the new dmg review staff of the FDA, which has agreed to reduce the NDA review time to 12 months by 1997 (6). 

Public s Capital, The. (1992). The Rising Tide of User Fees. In Governing-(April). Washington, DC Author. 

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. 

User fee cover sheet Financial disclosure information... 

Items I through 20 on the reverse side of the form constitute a check list that should be used to indicate the types of information contained within a particular submission. Please check all that apply. The numbering of the items on the checklist is not intended to specify a particular order for the inclusion of those sections into the submission. The applicant may include sections in any order, but the location of those sections within the submission should be clearly indicated in the Index. It is therefore recommended that, particularly for large submissions, the Index immediately follows the Form FDA 356h and, if applicable, the User Fee Cover Sheet (Form FDA 3397). 

The FDA are allowed 90 days to review a Traditional or Abbreviated 510(k) notification, and just 30 days for a Special 510(k). With the introduction of the Medical Device User Fee and Modernization Act of2002, provision was made for the participation of third-party organisations in the review process. This represents a partial adoption of the concept of Notified Bodies, which prevails in Europe. The FDA have accredited a number of commercial organisations to conduct primary 510(k) reviews of670 types of device. The FDA must then give a final determination within 30 days of receipt of the recommendation of a third-party reviewer. Because they are commercial, third-party reviewers will seek to offer faster review times in return for their review fee. If using a third-party reviewer, the FDA user fee does not apply. The outcome of a successful 510(k) notification is a letter from the FDA clearing the device for commercial sale. 

Identifies the device and gives a brief outiine of the device Table of Contents User Fee Information... 

A copy of a completed Medical Device User Fee Coversheet, which permits checking that the review fees have been paid... 

Households have direct and indirect costs. Direct household costs imply payments for transport to and from the health services, acconunodation for the accompanying relative, special buildings for disabled patients (e.g., changed bathroom), costs for diet, and the re-education, for instance new training after a paralysis. Private households also have to bear direct payments for user fees and drugs, which are an income of the providers. There must be clearing between these components of the COI to avoid double-counting. 

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. 

Medical devices were first made subject to FDA regulation under the FD C Act of 1938. At that time, the statute included no requirement for premarket testing or approval. Congress enacted the Medical Device Amendments of 19766 to require pre-market notification for all medical devices, and pre-market approval for some old and new devices for which there is no adequate assurance of safety and effectiveness. The 1976 Amendments established a broad new array of statutory requirements and enforcement provisions. This new regulatory approach was supplemented by the Safe Medical Devices Act of 1990 3 and further refined by the Medical Device Amendments of 1992,61 Food and Drug Administration Modernization Act of 1997,6 jj g Medical Devise User Fee and Modernization Act... 

The sponsor submits the NDA along with an appropriate application fee (currently in the range of 600 000), and the FDA reviews the apphcation for completeness, that is to determine whether all parts of the NDA are present, in particular the information critical for their review. If the NDA is complete enough for review it is filed (accepted) by the FDA. The agency has 60 days in which to perform this completeness review. The completeness review is important under user fee legislation, as the review clock... 

All substantial requests, whether received informally or through official notification, must be addressed as promptly and completely as possible. An attempt to gloss over an issue usually leads to further delay. Issues raised by the reviewer represent significant concerns and should be treated as such. The amount and type of any new information needed to answer a request must be carefully considered. Under user fee guidelines, the FDA likes to keep the review moving without the need to review large amounts of new data which, if too large, may... 

Nexoe, J., J. Kragstrup, and T. Ronne. 1997. Impact of Postal Invitations and User Fee on Influenza Vaccination Rates among the Elderly A Randomized Controlled Trial in General Practice. Scandinavian Journal of Primary Health Care 15(2) 109-112. 

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