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.
FDA Drug Pricing Policy Offers Short-Term PR Gain, More Long-Term Actual Benefit
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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The FDA generic drugs team’s first public workshop of the second Trump Administration ended with a request that industry amplify the value it finds from public engagement.
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