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User Fee Extensions Are Key To CDER's First Cycle Review Success

Executive Summary

Major amendments are replacing complete response letters when FDA has a problem with an NDA.

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US FDA May Start Missing ANDA User Fee Goals – In Order To Speed Approvals

Agency will work past generic goal dates if approval can be achieved quickly thereafter, but now must create policy defining criteria for those situations.

US FDA May Start Missing ANDA User Fee Goals – In Order To Speed Approvals

Agency will work past generic goal dates if approval can be achieved quickly thereafter, but now must create policy defining criteria for those situations.

NME Mid-Year Report: Approvals Might Near Record With Strong 2nd Half

CDER approved 23 new drugs in the first half of 2017, topping the 22 approved in all 2016; there are at least 18 products in CDER's pipeline with a user fee date this year.

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