News Headlines Article

FDA seeks faster patient access to experimental drugs
Modern Healthcare

The Food and Drug Administration wants to dramatically simplify and speed up the application process for access to investigational drugs.

The agency Wednesday introduced new draft guidance that includes a new application form for physicians to apply for experimental drugs not yet approved by the FDA under its expanded access program. Dr. Peter Lurie, the FDA’s associate commissioner for public health strategy and analysis, wrote in a blog post that the new application form would streamline the process and cut the amount of time needed to complete an application from the current 100 hours to just 45 minutes.