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ANDA Submission and GDUFA Guidance 2025
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(0 reviews)Monday, March 28, 2022 (1 day), San Jose, United States
Overview
Date: Mar 28, 2022 (1 day)
Venue 6201 America Center Drive, San Jose, CA 95002, USA, San Jose, United States
Organizer ComplianceOnline
An ANDA is an Abbreviated New Drug Application. This application is submitted to the FDA to seek approval to produce a U.S. generic drug from an existing patented approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs. After approval, the applicant is able to produce and market the generic drug product.
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