RettEd | What Comes Next? The FDA Regulatory Process from NDA to FDA Decision and Beyond

RettEd | What Comes Next? The FDA Regulatory Process from NDA to FDA Decision and Beyond

August 1, 2022 @ 3:00 pm – 4:00 pm America/New York Timezone

Date: Monday, August 1st, 2022
Time: 3 p.m. EDT

With the recent news about trofinetide’s new drug application (NDA) submitted to the FDA, we are entering a new space for Rett syndrome: FDA Review. While this is the first time for Rett, it won’t be the last, and our community has a lot of great questions:

“What does submitting an NDA mean? What’s the next step? How much longer? When will we have an approved treatment? How will my loved one get access to this treatment?”

To answer these questions and many more, IRSF is excited to bring back FDA expert, James Valentine, Esq., to join IRSF’s Chief Science Officer, Dr. Dominique Pichard for a live webinar. Join them as they review the FDA regulatory process, share what happens between a successful Phase 3 clinical trial and an FDA decision about a drug or therapeutic, and explain what could come next for trofinetide and the Rett community.

Thank you to our RettEd Empowerment Sponsor, Acadia Pharmaceuticals, for helping IRSF provide educational resources and support to families affected by Rett syndrome.


Medical Disclaimer: All information, content, and material provided in this webcast is for informational purposes only and is not intended to serve as a substitute for the consultation, diagnosis, and/or medical treatment of a qualified physician or healthcare provider. Always seek the advice of your physician or other qualified healthcare provider with any questions you may have regarding a medical condition.