Citizen petitions: FDA revises guidance to block drugmakers from abusing the system
The FDA on Tuesday issued a revised draft guidance designed to allow for the FDA to reject 505(q) petitions if the agency determines the primary purpose of the petition is to delay the approval of an abbreviated new drug application (ANDA).
“We believe this will provide an additional deterrent to pursuing these tactics,” the FDA said.
The new approach to reviewing petitions would also help the FDA focus its resources on addressing petitions that are most likely to present an obstacle to the availability of generic drugs.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.