Prescription Drug Users Fee Act PDUFA

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. 

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... 

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. )... 

FDA guidance for industry on Formal Meetings with Sponsors and Applicants for Prescription Drug User Fee Act (PDUFA) Products (February 2000)... 

Mannebach, A., Ward, M., and Adkins, B., 2006, Reviewing the Prescription Drug User Fee Act (PDUFA), Regulatory Rapporteur, September 2006, 12-16. 

More recently, activist groups and disease-based organizations have presented patients as sophisticated rational actors who can review medical information and make informed decisions for themselves. Changes in FDA regulations consequently shifted certain aspects of risk evaluation and decisionmaking control to patients and physicians. Initiatives since the peak of political attention to the AIDS crisis in the early 1990s, notably the 1992 Prescription Drug User Fee Act (PDUFA) and the 1997 FDA Modernization Act (FDAMA),... 

The Prescription Drug Users Fee Act (PDUFA, 1992) traded off fees paid upon NDA submission for performance standards on the part of FDA. This was the first time that any effective accountability had been applied to FDA, somewhat reversing the orientation of the Agency. PDUFA is due for reauthorization in 2002, and an analysis of its effect is being conducted by several industry and government organizations. 

Supplemental New Drug Applications must be done with careful consideration as to the type of supplement, the importance of it, and the urgency for approval. Caution must be given to each submission as the Prescription Drug User Fee Act (PDUFA) (www.fda.gov/cber/pdufa.htm). 

In the mid to later part of the 1990s, procedures were established to allow for more timely review and approval of marketing applications in the both European Union and the United States. The review process to be used and the timing for approval are defined by the local regulations, and are dependent upon the immediate therapeutic need for the product. The EU mutual recognition and centralized procedures and the U.S. Prescription Drug User Fee Act (PDUFA) will be discussed in more detail later in this chapter. 

The United States adopted a process known as the Prescription Drug User Fee Act (PDUFA), which defines the expected length of time for review of an original application. In exchange for a fee, the FDA agrees to render a decision on the application (approval, approvable under stated conditions, or not approved) within a period of time dictated by the nature of the new drug product. Currently, decisions on applications serving major therapeutic needs (IP compounds) will be... 

---