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FDA Week - 03/15/2019

Budget Aims To Narrow 5-Year Exclusivity, Boost FDA Petition Authority

March 11, 2019
The White House’s fiscal 2020 skinny budget released Monday (March 11) increases focus on FDA-related proposals that the administration believes could help lower drug costs by increasing competition. The budget calls for narrowly defining when a new drug is a new chemical entity and should receive five years of exclusivity, and giving FDA more flexibility to deny sham citizen petitions used to delay generic drugs. The administration also wants to ensure biological products do not have to meet the same...


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