ANDA Sponsors Get Wide-Open Facility Deadline For Priority Review
User fee legislation says facility information to qualify for priority review must arrive two months in advance of ANDA, conflicting with narrow 'window' in FDA's draft guidance.
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The 2017 user fee reauthorization bill contains provisions that should be significantly easier for the agency to implement compared with the 2012 measure. Senate clears clean bill for president's review.
An FDA guidance lists the criteria for reviewing “pre-submission facility correspondence” that permits expedited approval of priority generic drugs by allowing facility information to be reviewed prior to the submission of an ANDA. This mechanism was established by GDUFA II.