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Communicating with FDA Toolkit

One of the most important aspects for any drug development program is proper interaction with regulatory authorities like the US Food and Drug Administration (FDA). Clear communication with the FDA can greatly increase the chances of getting your drug approved.

In this toolkit, you will find essential resources to improve your communication with the FDA including: do’s and don’ts for communicating effectively with the FDA, questions & answers with former FDA reviewers, cheat sheet for meeting types, and relevant FDA guidances.

You will benefit from first-hand experience and advice from Nuventra consultants Gene Williams and Iftekhar Mahmood, who both spent over 20 years as clinical pharmacology reviewers at the FDA.

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Communicating with the FDA Toolkit