To amend the Federal Food, Drug, and Cosmetic Act with respect to the accelerated approval of a product for a serious or life-threatening disease or condition, and for other purposes.
Accelerating Access for Patients Act of 2022
This bill modifies requirements relating to accelerated approval of drugs for serious or life-threatening diseases or conditions, including by requiring guidance from the Food and Drug Administration and coordinated plans with product sponsors on appropriate postapproval studies.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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