PDUFA VII to expand FDA’s real-time oncology reviews to supplements for all therapeutic areas
The FDA’s popular program to speed up its reviews of new oncology drugs and supplemental applications by months will be expanded into a larger program for efficacy supplements across all therapeutic areas.
The new program, to be known as Split Real-Time Application Review (STAR), first came to light in the minutes of a December meeting of the premarket subgroup working on the negotiation of the latest iteration of the Prescription Drug User Fee Act (PDUFA VII).
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.