Trump FY 2020 Budget Renews Push To Reform 180-Day Exclusivity
Executive Summary
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.
You may also be interested in...
Worries About 180-Day Exclusivity Reforms Persist As User Fee Bill Advances
FDA-crafted legislative text emerges that generic industry says could weaken the incentive, but so far no changes are in the draft House and Senate bills.
Worries About 180-Day Exclusivity Reforms Persist As User Fee Bill Advances
FDA-crafted legislative text emerges that generic industry says could weaken the incentive, but so far no changes are in the draft House and Senate bills.
180-Day Exclusivity Changes Pushed In Biden’s Budget Proposal
The legislative proposal would make first-filer exclusivity function similar to the competitive generic therapy program, allowing additional approvals if the commercial launch is delayed.