Pre-ANDA Meeting or Controlled Correspondence? (4of28) Generic Drugs Forum – Apr. 3-4, 2019

Описание: CDER Office of Pharmaceutical Quality’s (OPQ) Bhagwant Rege and Kris Andre, Associate Director of Regulatory Affairs in the Office of Generic Drugs (OGD), discuss when to use controlled correspondence and when it may be more effective than a meeting. They review how to obtain agency feedback on inactive ingredients in a proposed generic product and share how pre-submission meetings allow you to discuss the format and content of the ANDA to be submitted.

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