Trump's Budget Request To Include ANDA Exclusivity Changes
Executive Summary
180-day exclusivity would begin when a second ANDA is approvable, rather than at first-generic's launch, a potentially major change to the Hatch-Waxman framework if implemented.
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Trump FY 2020 Budget Renews Push To Reform 180-Day Exclusivity
US FDA would get an overall increase in funding under the president's fiscal year 2020 budget proposal, although the generic drug industry opposes reforms targeting the 180-day exclusivity clock for first filers.
Are 180-Day Exclusivity Changes Moving Out Of Drug Pricing Plans?
US FDA softens its tone on idea and encourages industry to voice its (predominantly negative) opinion publicly.
Are 180-Day Exclusivity Changes Moving Out Of Drug Pricing Plans?
US FDA softens its tone on idea and encourages industry to voice its (predominantly negative) opinion publicly.
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