Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period

Conclusions:
The expanded access program is viewed as a success from FDA’s perspective based on the large number of applications processed and allowed to proceed each year. However, the actual number of patients and their health care providers that desire drug treatments available under expanded access is not known. It is exceedingly rare for a serious adverse event under expanded access to affect the development program for that drug.

Source: Therapeutic Innovation and Regulatory Science - October 23, 2016 Category: Drugs & Pharmacology Authors: Jarow, J. P., Lemery, S., Bugin, K., Khozin, S., Moscicki, R. Tags: Regulatory Science Source Type: research