To amend the Federal Food, Drug, and Cosmetic Act to strengthen requirements for postapproval studies for drugs approved using accelerated approval, and for other purposes.
Accelerated Approval Integrity Act of 2022
This bill establishes requirements relating to postapproval studies for drugs that receive accelerated approval for serious or life-threatening diseases or conditions, such as requiring product sponsors to agree in advance to conduct such studies and terminating product approval if certain benchmarks are not met.
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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