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Code · BILL · 117th Congress · H.R. 6000 (Introduced in House) — To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes. · Sec. 309

Sec. 309. Post-approval study requirements for accelerated approval

46 words·~1 min read·/bill/117/hr/6000/ih/section-309·

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Section 506(c)(2)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356(c)(2)(A) ) is amended after studies by inserting , or otherwise submit evidence based on analyses of data in clinical care data repositories, patient registries, or other sources of real world evidence, .
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Sec. 309
Post-approval study requirements for accelerated approval
U.S.C.§ 356
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