Sec. 204. Patient experience data

292 words·~1 min read·/bill/117/hr/6000/ih/section-204

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

Section 569C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–8c ) is amended— by redesignating subsections

(b)and

(c)as subsections

(c)and (d), respectively; and by inserting after subsection

(a)the following new subsection: The Secretary shall— for any drug for which an exemption is granted for investigational use under section 505(i) of this Act or section 351(a) of the Public Health Service Act, require the sponsor of the drug to collect standardized patient experience data as part of the clinical trials conducted pursuant to such exemption; require any application for the approval or licensing of such drug under section 505(b) of this Act or section 351(a) of the Public Health Service Act to include— the standardized patient experience data so collected; and such related information as the Secretary may require; and consider patient experience data and related information that is submitted pursuant to subparagraph

(B)in deciding whether to approve or license, as applicable, the drug involved. Paragraph

(1)applies only with respect to drugs for which a request for an exemption described in paragraph (1)(A) is submitted on or after the date of the enactment of the Cures 2.0 Act , or an application under section 505(b) of this Act or section 351(a) of the Public Health Service Act is filed, as applicable, on or after the day that is 2 years after the date of the enactment of the Cures 2.0 Act . . Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall promulgate final regulations to implement section 569C(b) of the Federal Food, Drug, and Cosmetic Act, as added by this section.

Connections1 off-index

1 reference not yet in our index

21 USC 360bbb–8c

Citation graph

cites case law

Sec. 204

Patient experience data

Cite21 USC 360bbb–8c

Cites 1Cited by 0 across 0 sources