FDA Forms Internal Generic Policy Group

August 9, 2017 at 1:20 PM
FDA has formed an internal group to evaluate policies to modernize the agency's approach to the Hatch-Waxman generic pathway law, an FDA spokesperson tells Inside Health Policy . Commissioner Scott Gottlieb has also said the new group will be tasked with crafting new generic competition policy proposals. The working group's formation comes on the heels of FDA's public meeting on Hatch-Waxman, and as FDA develops a plan to incentivize generic competition. “The group will evaluate policy steps we can take...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.