Key actions to be taken by the FDA to advance development of coronavirus medical countermeasures

The US Food and Drug Administration (FDA) has announced critical actions to expedite the development and availability of medical products needed for the diagnosis, treatment and prevention of the coronavirus and related future outbreaks. Read more “Key actions to be taken by the FDA to advance development of coronavirus medical countermeasures”

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. Read more “What is the benefit of the FDA’s new app for reporting novel uses of infectious disease drugs?”

The FDA plans to implement e-submission of safety reports for investigational new drug (IND) applications

The United States (US) Food and Drug Administration (FDA) is taking steps towards making electronic submission of safety reports for investigational new drug applications (INDs) into their Adverse Event Reporting System (FAERS), a requirement. Read more “The FDA plans to implement e-submission of safety reports for investigational new drug (IND) applications”