Drug Information Update - FDA's Breakthrough Therapy Designation and Expedited Review Programs

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

For more than two decades, CDER has employed expedited pathways aimed at speeding the drug development and review processes so that therapies that show early promise can reach patients faster. The popularity and value of these programs has grown so much during this time that over half of CDER’s 2015 novel drug approvals received some form of expedited review.

In this two part interview, Dr. Rich Moscicki takes a deep dive into FDA’s Breakthrough Therapy designation to help clarify common misunderstandings around this expedited program. Dr. Moscicki also breaks down each of CDER’s expedited pathways to help readers understand not only the lingo, but also the implications of expedited reviews and approvals.

For more information, please visit the latest CDER Conversation: FDA’s Breakthrough Therapy Designation and Expedited Review Programs.