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.
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