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FDA Drug Pricing Policy Offers Short-Term PR Gain, More Long-Term Actual Benefit

 
• By Derrick Gingery

Prioritizing ANDAs entering markets with fewer than three approved generics not expected to become a major advantage until first-cycle clearances increase.

FDA entrance sign 2016

FDA appears poised to more quickly increase generic competition with its expanded ANDA prioritization policy, but stakeholders may be disappointed if they expect any immediate gratification from the changes.

Instead of offering priority only to first generics, the agency now will offer it for generics where there are "fewer...

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