FDA Drug Pricing Policy Offers Short-Term PR Gain, More Long-Term Actual Benefit
Executive Summary
Prioritizing ANDAs entering markets with fewer than three approved generics not expected to become a major advantage until first-cycle clearances increase.
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Inside The ANDA Parking Lot
A firm will take ownership of US ANDAs from manufacturers unwilling to pay program fees or withdraw the approved generic drug application; is it a novel concept allowing future marketing options or simply fee avoidance?
Inside The ANDA Parking Lot
A firm will take ownership of US ANDAs from manufacturers unwilling to pay program fees or withdraw the approved generic drug application; is it a novel concept allowing future marketing options or simply fee avoidance?
In Switching Generic 'Reviews' To 'Assessments' Is US FDA Changing More Than Just A Word?
MaPP revision may be just a better description of ANDA evaluations – or indicative of a broad culture change, experts tell the Pink Sheet.