FDA Draft Guidance Aims To Reduce Processing Time for Applications to the Expanded Access Program
FDA on Wednesday released draft guidance that would reduce the amount of time physicians need to complete an application for the agency's expanded access program from about 100 hours to 45 minutes, according to an FDA official. The FDA program, also known as "compassionate use," allows individuals with serious or life-threatening diseases to access experimental drugs outside of a clinical trial if they have no comparable alternatives. In a blog post, Peter Lurie, FDA's associate commissioner for public health strategy and analysis, wrote, "The new draft guidance and draft form are the latest examples of FDA's determined effort to minimize unnecessary red tape, increase efficiency and better serve patients in need."
- "FDA Seeks Faster Patient Access to Experimental Drugs" (Ross Johnson, Modern Healthcare, 2/4).