To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review.

Bill: 114-hr-2433
Sponsor: full_name: Rep. Bilirakis, Gus M. [R-FL-12]
Introduced: 2015-05-19
Policy area: Health
Subjects: Administrative law and regulatory procedures

Department of Health and Human Services

Drug safety, medical device, and laboratory regulation

Food and Drug Administration (FDA)
Latest action: action_date: 2015-05-22
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2015-05-19
action_desc: Introduced in House
text: <p>This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration to describe the responsibilities of each agency center charged with reviewing drugs, medical devices, or biological products when reviewing a product that is a combination of drug, medical device, or biological product.</p>

tv_txt: 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. .