Posted by Michael Wonder on 24 Sep 2017
Generics industry calls FDA draft guidance on priority reviews 'basically inoperable'
22 September 2017 - A generic drug industry group and several companies have taken issue with recent US FDA draft guidance on pre-submission facility correspondence that spells out what companies need to do to obtain faster abbreviated new drug application reviews.
In June, FDA released the draft guidance noting that it is "critical" for there to be a two-month lead time to determine whether facility inspections will be needed for the 8-month, rather than the 10-month abbreviated new drug application (ANDA) reviews, and if necessary, to initiate inspection planning earlier in the review.
Calling the draft "a fundamental departure" from what was agreed in the user fee negotiations, the industry group known as the Association for Accessible Medicines said in its comment dated Monday that it "has significant concerns" as it "may unintentionally discourage ANDA sponsors from submitting a priority review request."
