The US Food and Drug Administration (FDA) and the Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA) will hold a webinar, "Overview of GDUFA II and Implementation of GDUFA II User Fees," on Friday October 28 at 1:00 PM EST.
The CDER SBIA webinars focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.
Earlier this year, the FDA, the generic drug manufacturing industry —including representatives of generic pharmaceutical manufacturers, active pharmaceutical ingredient (API) manufacturers, and contract manufacturing organizations—reached agreement on a package of program enhancements and resource commitments to reauthorize the Generic Drug User Fee Amendments of 2012 (GDUFA), which are set to expire next year.
Under GDUFA, the industry is required to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities. These additional resources were intended to support the FDA's efforts to reduce a backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections. GDUFA is also designed to enhance global supply-chain safety by requiring that generic drug facilities and sites around the world self-identify. The current legislative authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years.
The 60-minute live webinar, which will include a question and answer portion, will provide a brief overview of changes to the user fee structure under the proposed reauthorization of GDUFA II and what it means for regulated industry. The webinar will discuss those changes to the user fee structure under GDUFA II and will describe how CDER and Industry can best prepare for GDUFA II go-live on October 1, 2017.
Information to register for the webinar may be found here.