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.”

Ask the Accelerators is a series highlighting the perspectives and work of organizations and individuals participating in the COVID-19 Evidence Accelerator. Organized by the Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA) and Friends of Cancer Research, the COVID-19 Evidence Accelerator joins leaders in the health care data and analytics space to explore how real-world data (RWD) can inform key COVID-19 research questions. 

When a patient is in need of an important medicine, paperwork and forms are the last thing their physician wants to deal with. In some cases, it’s necessary, but the U.S. Food and Drug Administration is doing everything we can to keep it to a minimum. Our expanded access program is one example. 

On February 4, 2020, the U.S. secretary of health and human services declared that emergency use of diagnostics for SARS-CoV-2 was justified, triggering emergency authority for the Food and Drug Administration (FDA) to grant an emergency use authorization (EUA) for a device if it reasonably believes that it may be effective, rather than waiting to grant full approval when it has reasonable assurance that the device is safe and effective.

Ask the Accelerators is a series highlighting the perspectives and work of organizations and individuals participating in the COVID-19 Evidence Accelerator. Organized by the Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA) and Friends of Cancer Research, the COVID-19 Evidence Accelerator joins leaders in the health care data and analytics space to explore how real-world data (RWD) can inform key COVID-19 research questions.

Former FDA chief Scott Gottlieb’s favorite real-world evidence platform is getting a new stream of cash, as it nears what will likely be the biggest test of the young company so far.

Aetion, the New York health tech startup, has for the second time raised an extension to their Series B, adding $19 million from J&J’s VC arm, Greenspring Associates and EDBI to bring their round to $82 million. Gottlieb, who championed real-world evidence as commissioner and later joined the company’s board, said in a statement that the new cash would help fuel a global expansion.

The U. S. Food and Drug Administration has been proactive and supportive of test development by all comers — including laboratories, and large and small commercial manufacturers — to speed development and to quickly authorize tests that the science supports.

Traditionally, the healthcare industry has moved slowly when embracing new technology innovations.

However, over the past few months, it has been forced to rapidly advance to confront the challenges posed by COVID-19. One area that has received increased attention is real-world data (RWD), specifically, the ways in which RWD can be used in clinical research to quickly reveal insights about treatments, outcomes, and risk factors for COVID-19.

The FDA will participate in the Covid-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research.

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At a Medical Device Innovation Consortium fireside chat Thursday, FDA Commissioner Stephen Hahn said the agency will take a fresh look at how it regulates diagnostics and digital technologies after the coronavirus pandemic.

The FDA will be working to provide industry what data it believes is needed “to make that first assessment of patient safety, according to Hahn.

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