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. You will also benefit from first-hand experience and advice from Nuventra consultants Gene Williams and Brian Furmanski, who spent a combined 23 years as Clinical Pharmacology Reviewers at the FDA. The five sections include:
- Part 1: Communicating Effectively with the FDA; Roles & Responsibilities / Dos & Don’ts
- Part 2: Questions & Answers with Former FDA Reviewers
- Part 3: Cheat Sheet: Meeting Types and Timing
- Part 4: Relevant Guidances from the FDA
- Part 5: Meet Nuventra’s Former FDA Reviewers
Complete this form to request your Toolkit for Communicating with the FDA: