What is the minimum and maximum time taken for the grant of an NDA, by USFDA, in the year 2010?

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Lakshmana Pramod's picture

The legal basis for reviewing of NDA in US is The Prescription Drug User Fee Act (PDUFA). The Prescription Drug User Fee Act (PDUFA), first enacted in 1992 and reauthorized thrice (referred to as PDUFA II, PDUFA III & PDUFA IV- 2007). The review time is depends upon the type of application i.e. Standard or priority, type of Molecule i.e. New Molecular entity or new formulation of existing molecule. In 1993, median total approval time for CDER was 27 months for standard NDAs classified as new molecular entities; in 2001 it was 19 months. The Prescription Drug User Fee Act and the Food and Drug Administration Modernization Act PDUFA I: In response to the public's demand for greater access to new drugs to treat life-threatening illnesses, the 1992 Prescription Drug User Fee Act, referred to as PDUFA I, was enacted. The main purpose of PDUFA I was to reduce the time it takes FDA to review new drugs for market approval. It authorized FDA to collect user fees from sponsors to be used towards speeding up the NDA review process. It also established time goals for FDA's review of NDAs. PDUFA II: In 1997, user fees were reauthorized as part of the Food and Drug Administration Modernization Act. The section of the Act that addresses user fees, referred to as PDUFA II, tightened the deadlines in the goals. It also added new provisions to help speed up the entire drug development process. Most notably, it required FDA to meet with sponsors upon request and codified many existing FDA policies intended to bring life-saving treatments to market faster. PDUFA III: In June 2002, user fees were once again reauthorized referred to as PDUFA III, as part of the Public Health Security and Bioterrorism Preparedness Act of 2002. Most notably, PDUFA III increases user fees to help provide FDA with additional resources. PDUFA IV: In January 2007, FDA released its proposal for PDUFA IV. The goals, developed through consultation with Congress, industry, and healthcare consumers and professionals, focus on securing FDA's sound financial footing, and enhancing both premarket review and the post market safety system. Review process: Under PDUFA, when FDA gets an NDA, the agreement is FDA will do a complete review in a certain time period. At the end of that review, FDA can either approve the drug or tell the sponsor that it is not ready to be approved and there are things that need to be fixed. After successful review applicant receives the complete response letter. This includes list of discrepancies. When a sponsor submits a complete response to a Complete Response letter, a new review cycle and a new review clock is started. The response must be complete for the clock to start; partial responses do not restart the clock. Resubmissions are categorized as either Class 1 or Class 2. Class 1 resubmissions are those that respond to minor deficiencies, such as labeling comments and do not require review of large amounts of new data. Class 1 resubmissions receive a two-month clock. Class 2 resubmissions are those that contain more extensive new data for review, and they receive a six-month clock. FDA determines whether a resubmission is Class 1 or Class 2 based on criteria that are spelled out in the PDUFA Goals Letter.

G.L.Pramod, B.Pharmacy, MS.c(Ph.Regulatory Affairs), Executive, EU Regulatoty Affairs, ELC, Ahemdabad.

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