FDA Week - 12/07/2018

In bid to cut back on multiple application reviews . . .

FDA Clarifies Procedures For Generics To Request Meetings Post-CRL

By Beth Wang / December 3, 2018 at 7:23 PM
In a further bid to streamline generic drug development, FDA on Monday (Dec. 3) clarified the procedures for generic drug makers to request meetings with the agency after receiving complete response letters (CRL) indicating deficiencies in their applications. The information, provided via final guidance, is intended to meet the goals of the latest generic drug user fees by helping to cut down on the number of review cycles needed to approve a drug, which could make the development process more...


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