publication date: Sep. 25, 2020

Drugs & Targets

Expanded access eRequest app allows physicians to submit EA requests online

The Reagan-Udall Foundation for the FDA, with input from experts at FDA, has introduced an Expanded Access eRequest app to streamline expanded access for individual patients in non-emergency settings.

“Time is critical when patients have a serious or life-threatening disease or condition and do not have other therapeutic options,” FDA Principal Deputy Commissioner Amy Abernethy said in a statement. “We want to make it easier for physicians to apply for expanded access for their patients and allow these health care providers to focus on the clinical aspects of care.”

The eRequest online app walks physicians and other healthcare providers screen-by-screen through the expanded access process—from determining if expanded access is appropriate for their patient to submitting the request to FDA.

eRequest’s home on the Foundation’s Expanded Access Navigator means physicians can identify potential investigational therapies; access sponsor information; complete, sign, and submit FDA Form 3926; upload supporting documentation; and review additional

resources all in one place.

The app is compatible with multiple devices, so physicians can explore expanded access in real time with their patient and then submit the request when completed.

 

FDA accepts for priority review application for anti-BCMA CAR T-cell therapy idecabtagene vicleucel (Ide-cel, bb2121)

FDA has accepted the Biologics License Application for idecabtagene vicleucel (ide-cel; bb2121) as Priority Review.

Idecabtagene vicleucel is an investigational B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy, for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. FDA … Continue reading Expanded access eRequest app allows physicians to submit EA requests online

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