What is the benefit of the FDA’s new app for reporting novel uses of infectious disease drugs?

The United States (US) Food and Drug Administration (FDA) have launched an application (app) for global health-care professionals (HCPs) to report novel uses of existing medicine for patients with rare and difficult-to-treat infectious diseases.

HCPs can access the app through the internet, smartphone or other devices. The internet-based platform will enable the “crowdsourcing” of medical information from HCPs to facilitate potentially life-saving interventions and development of new drug indications for uncommon diseases.

It will include a news feed, improved search functionality, nearly 1,500 case reports and published literature from more than 18,000 clinical trials. HCPs will be able to browse through submitted case reports, review information from relevant clinical trials and discuss treatments with peers.

“Our hope is that this app will serve as a connector among major treatment centres, academics, private practitioners, government facilities and other health care professionals from around the world and ultimately get treatments to patients faster.” 

The FDA’s aim is to make it quicker and easier to identify promising off-label uses for already approved drugs that could eventually lead to new approved indications for those products. Clinical outcomes of novel drug uses in new populations, doses or combinations can be reported, essentially allowing the systematic collection of real-world evidence to enhance drug development.

For more information, click here.