CDER Impact Story on How Modeling Was Used to Support the FDA Approval of a Topical Generic Drug Product - Drug Information Update

If your email program has trouble displaying this email, view it as a web page. How Modeling Was Used to Support the FDA Approval of a Topical Generic Drug Product CDER encourages generic sponsors to consider novel quantitative tools as described in agency guidances. Recently, PBPK modeling supported a bioequivalence determination that allowed for the first ANDA approval of a generic topical gel. Learn More This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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