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Code · BILL · 114th Congress · H.R. 6 (Reported in House) — To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes. · Sec. 2181

Sec. 2181. Enhancing combination products review

78 words·~1 min read·/bill/114/hr/6/rh/section-2181

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Section 503(g)(4)(C) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(g)(4)(C) ) is amended by adding at the end the following new clause: Not later than 18 months after the date of the enactment of the 21st Century Cures Act , the Secretary shall issue final guidance that describes the responsibilities of each agency center regarding its review of combination products. The Secretary shall, after soliciting public comment, review and update the guidance periodically. .
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Sec. 2181
Enhancing combination products review
U.S.C.§ 353
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