Learn about strategies for Leveraging Real-World Treatment Experience from Expanded Access Protocols in the report from our November public meeting at the FDA White Oak Campus. We brought all the stakeholders together --- patient advocates, physicians, industry and regulators --- for input.
The FDA updated its guidance to clarify that listing in our Expanded Access Navigator Company Directory satisfies the 21st Century Cures Act requirement of making EA policies readily available. Read "How should we post our expanded access policy?" for detail.
The Reagan-Udall Foundation for the Food and Drug Administration expands its leadership with the appointment of three new Board members: Andrew C. von Eschenbach, M.D., former FDA Commissioner; Edward John Allera JD, pharmacist and attorney with expertise in FDA regulation and biotechnology; and, Lynne Zydowsky, Ph.D., a biotechnology and life science executive.
Read the full press release here.
We're excited to honor two longtime U.S. Food and Drug Administration leaders and an independent public-private partnership as the 2018 recipients of the Innovations in Regulatory Science Awards to be honored on December 4, 2018.
Our Executive Director June S. Wasser has agreed to serve on the advisory panel for a new initiative of the Grocery Manufacturers Association Science and Education Foundation (GMA SEF). In this capacity Wasser will be an external reviewer of the next instructional unit being developed for the Hands On: Real World Lessons for Middle School Classrooms program. The current curriculum, often referred to as Hands On: Food Safety is being used in over 30 states and has reached more than 64,000 students, and 1,000 teachers since its inception.
The Reagan-Udall Foundation for the Food and Drug Administration is pleased to announce the call for nominations for the 2018 Innovations in Regulatory Science Awards. The Foundation will be honoring the leadership and achievements of those whose work represents the progress and promise of regulatory science and advocacy.
Each year the Foundation conducts an annual meeting, open to the public, to discuss its activities and how it supports FDA. This year's meeting takes place May 4th, from 10 a.m until noon, at the law offices of Alston and Bird (950 F St. NW, Washington, DC) and concludes with a period for brief comments from the public, which can be submitted in advance by emailing eshaefer@reaganudall.org.
"Evolution of FDA Science and Engagement" - a panel discussion
Right-To-Try law not a shortcut to investigational drugs – Expanded Access Navigator can reduce confusion.
Serious or terminally ill patients hoping House passage of federal Right-To-Try legislation will bypass hurdles to unapproved medical treatments need accurate, neutral information now more than ever.
The secret's out, and we're excited to honor the two leaders who will be receiving the inaugural Innovations in Regulatory Science Awards at the Gala December 5th. Here's the press release we shared with media and sponsors.
Nominations are now being accepted for the Innovations in Regulatory Science Awards. These awards will be presented at the inaugural Innovations in Regulatory Science Awards Gala on December 5th, 2017 at the Kaiser Permanente Center for Total Health in Washington, D.C.
The Innovations in Regulatory Science Awards will be presented in two categories to honor individuals and organizations for their accomplishments and service to regulatory science and public health.
