FDA requests comments on 'first generic' ANDA submissions

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday opened a public docket and requested comments on proposed criteria for “first generic” abbreviated new drug application submissions.

 

According to the agency, establishing clear criteria for this review prioritization category will allow FDA to appropriately prioritize ANDA submissions and track them in a manner consistent with the review prioritization commitments FDA made pursuant to Generic Drug User Fee Amendments of 2012. Clear criteria for this category will also lead to less industry confusion and more consistent identification of “first generic” submissions.  

 

FDA believes that these proposed criteria appropriately focus FDA’s resources on approving new safe and effective generic drug products for patient use as quickly as possible,.