CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry: ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA II
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 7/3/2018, the FDA issued the Guidance for Industry: ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA II.
This guidance explains how the review goals established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to amendments, to either abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) submitted to the FDA under section 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C 355(j)). This guidance describes amendment classifications and categories and explains how amendment submissions may affect an application’s review goal dates. The guidance also describes how FDA should assess amendments submitted to ANDAs and PASs received prior to October 1, 2017, which is the GDUFA II review goals effective date.
FDA issued this webinar as a companion to the draft versions of the above guidance in October, 2017. The information presented is also relevant to the final guidance.
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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