CDER Small Business and Industry Assistance (CDER SBIA) Webinar on Guidance for Industry: ANDA Submissions – Content and Format of Abbreviated New Drug Applications – June 12, 2014
The Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA) is pleased to inform you of a unique opportunity for small business entities to learn more about the FDA and basic drug regulation. Our webinar series highlights various aspects of drug regulation.
These focused webinars support the 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 Thursday June 12, 2014, CDER Small Business and Industry Assistance (CDER SBIA) announced the availability of a webinar entitled Guidance for Industry: ANDA Submissions – Content and Format of Abbreviated New Drug
FDA published a notice in the Federal Register announcing the availability of draft guidance for industry, entitled ANDA Submissions--Content and Format of Abbreviated New Drug Applications.
FDA is issuing this guidance to assist ANDA applicants in improving the quality of submissions, to increase the number of original ANDAs acknowledged for receipt upon initial submission, and to decrease the number of review cycles. The draft guidance provides comprehensive assistance for the early stages of the application process so that an original ANDA will contain all information necessary for FDA to complete its review.
Elizabeth Giaquinto, JD
Office of Policy
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
Elizabeth Giaquinto is a regulatory counsel in the Office of Policy, Office of GenericDrugs (OGD). Before joining OGD in October, 2013, Ms. Giaquinto was a staff member in CDER’s Office of Executive Programs since 2008. Ms. Giaquinto holds J.D. and LL.M. degrees from Seton Hall University School of Law.
- Webinar access link: https://collaboration.fda.gov/p6kfmalydi8/
- Download Presentation Slides: Overview: Draft Guidance for Industry: ANDA Submissions - Content and Format of Abbreviated New Drug Applications (PDF – 279KB)
- FR Document: 2014-13641 Docket No. FDA-2014-D-0725
- Draft Guidance: ANDA Submissions--Content and Format of Abbreviated New Drug Applications.
For questions concerning the webinar, please contact CDER SBIA at:
(866) 405-5367 | (301) 796-6707
CDER SBIA webinar series: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm070334.htm
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