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Code · BILL · 113th Congress · H.R. 4879 (Introduced in House) — To amend the Federal Food, Drug, and Cosmetic Act to provide for expedited review of drugs and biological products to... · Sec. 2

Sec. 2. Sufficiency of design and size of clinical trials during expedited review

70 words·~1 min read·/bill/113/hr/4879/ih/section-2

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The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall review and develop policies, as appropriate, to ensure that the design and size of clinical trials for products granted expedited approval pursuant to section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) are sufficient to determine the safety and effectiveness of such products for men and women using subgroup analysis.
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Sec. 2
Sufficiency of design and size of clinical trials during expedited review
U.S.C.§ 356
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