The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), invites you to our webinar series.
These events 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.
On 10/2/2017, the FDA issued the Draft Guidance for Industry: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA.
This draft guidance describes the enhanced process for discussions between FDA and a prospective applicant preparing to submit (or an applicant that has submitted) an Abbreviated New Drug Application (ANDA) for a complex generic drug product to FDA. The guidance provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review-cycle meetings with FDA.
FDA is issuing this webinar to assist ANDA applicants and prospective applicants in creating and submitting meeting requests, including meeting package materials, for formal meetings with FDA regarding complex generic drug products as defined in the Generic Drug User Fee Amendments Reauthorization (GDUFA II) Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Goals or Commitment Letter).
Elizabeth Giaquinto Friedman, JD, LLM
Office of Generic Drugs
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
For questions concerning the webinar, please contact CDER SBIA at:
(866) 405-5367 | (301) 796-6707
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