The Reagan-Udall Foundation for the FDA launched an online COVID-19 Treatment Hub to help patients, caregivers, physicians and other healthcare providers find COVID-19 treatment resources as quickly as possible. The Hub represents a critical enhancement of the existing Expanded Access Navigator, which was developed at the request of the U.S. Food and Drug Administration to help facilitate pre-approval to drugs.
What does the HUB do?
It helps users (patients and their families, caregivers, physicians, healthcare professionals, etc.) sift through the new clinical trials being announced every day as government, academia, and the global biopharmaceutical industry rally to find solutions to the pandemic.
The COVID-19 Treatment Hub also includes a directory of companies developing COVID-19 therapies, a searchable listing of relevant clinical trials and expanded access opportunities culled from ClinicalTrials.gov, and links to the latest FDA, CDC and NIH updates. The COVID-19 Treatment Hub also links to key FDA resources for consumers and industry focused on food and veterinary safety.
Ellen Sigal, PhD, Chair of organization, pointed out their gratitude to the FDA in supporting them to “make it easier for the public and for healthcare providers to navigate through the information and to find credible resources in one place.”
Who is the Reagan-Udall Foundation?
A private nonprofit (501c3) organization, they were created to support the mission of the U.S. Food and Drug Administration. They strive to help equip FDA staff with the highest caliber regulatory, science and technology in order to enhance the safety and effectiveness of FDA regulated products.
This nonprofit, interestingly, was mandated by Congress as part of the Food and Drug Administration Act of 2007 to help support and promote FDA’s regulatory science priorities, its independent of the agency inclusive of its own Board of Directors, staff and research agenda. Moreover, this organization helps create public-private partnerships to advance research in regulatory science, enhance medical decision making and promote innovation. They also offer fellowships and training programs for both scientists and for FDA staff.
TrialSite News Comments
TrialSite News has received many requests to share various hubs, portals and websites that consolidate, curate and present what is purported to be concise views into the world of COVID-19 clinical trials. Unfortunately, backers of these offerings ultimately look at this pandemic as a way to drive more business toward whatever their pursuit is. Of course, there is no wrong in that per se, but we have politely declined any of these offers. In the case of the Reagan-Udall Foundation Expanded Access Navigator for COVID-19, we showcase this update. It is the result of a program to help the public—in fact, it was congressionally mandated that such a nonprofit group be set up alongside to support the FDA.