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FPWR and PWSA | USA Announce Upcoming Meeting with FDA

The meeting with the FDA will allow us to share our rare communities’ perspective and ensure the FDA has a full understanding of the unique challenges of PWS.

With your support, FPWR and PWSA | USA have been granted a meeting with the FDA, which will take place via teleconference later this month. This small, non-public meeting will allow FPWR and PWSA | USA to connect first-hand with the FDA staff and share important information that should be considered during the review of new drugs for PWS. While the meeting will not be about a specific drug, it will allow us to share our rare communities’ perspective and ensure the FDA has a full understanding of the unique challenges of PWS, with a particular focus on issues related to clinical trials.

During the meeting we will:

  • Review PWS patient experience data that documents unmet medical need, severity of PWS, and treatment preferences and priorities
  • Share the impact of the COVID-19 pandemic on PWS families and its implications for clinical trials
  • Share the community’s tolerance for risk for even modest improvements in PWS-associated behaviors
  • Discuss the Agency’s perspective on how regulatory flexibility can be applied to efficiently advance new medical products that are safe and effective for PWS
  • Invite the FDA to ask further questions that will help them better understand our treatment needs and preferences moving forward

We thank our community of supporters for taking action and supporting our joint advocacy efforts. We look forward to sharing a post-meeting summary with you soon!

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Topics: News

Susan Hedstrom

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Susan Hedstrom is the Executive Director for the Foundation for Prader-Willi Research. Passionate about finding treatments for PWS, Susan joined FPWR in 2009 shortly after her son, Jayden, was diagnosed with Prader-Willi Syndrome. Rather than accepting PWS as it has been defined, Susan has chosen to work with a team of pro-active and tireless individuals to accelerate PWS research in order to change the future of PWS. Inspired by her first FPWR conference and the team of researchers that were working to find answers for the syndrome, she joined the FPWR team in 2010 and led the development of the One SMALL Step walk program. Under Susan’s leadership, over $15 million has been raised for PWS related research.