The FDA is implementing a new pilot program that could incentivize development of certain new drugs by dramatically shortening their regulatory reviews. But to qualify, a drug must address specified ...

Reviews are thorough and require 12-18 months to complete. Brief descriptions of the individual process elements with linked guides and templates are provided below. A complete overview of the process ...

A gene therapy for hearing loss. A drug that helps people quit e-cigarettes or vaping. An anesthetic whose main ingredient will be manufactured in the U.S. These are among the first nine therapies ...

Over the past year, the Program Performance Review Committee developed an Annual Program Review (APR) process that will be timelier and more meaningful, along with two complementary dashboards. The ...