Library / Laws / 114th / hr / H.R. 2433 / Introduced in House
I
114th CONGRESS
1st Session
H. R. 2433
IN THE HOUSE OF REPRESENTATIVES
May 19, 2015
Mr. Bilirakis introduced the following bill; which was referred to the Committee on Energy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review.
1.
Enhancing combination products review
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:
(iii) 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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