180-Day Exclusivity Changes Pushed In Biden’s Budget Proposal

 
• By Derrick Gingery

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.

No ANDA parking
The FDA still wants to crack down on generic exclusivity "parking." • Source: Nielsen Hobbs; the Pink Sheet | Alamy, Shutterstock images

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