Sec. 3001. PATIENT EXPERIENCE DATA
383 words·~2 min read·
/statute-compilations/comps-13005/sec-3001A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
## SEC. 3001 PATIENT EXPERIENCE DATA Section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-8c) is amended— ####
(1)in subsection (a)— #####
(A)in the subsection heading, by striking “In General” and inserting “Patient Engagement in Drugs and Devices”; #####
(B)by redesignating paragraphs
(1)and
(2)as subparagraphs
(A)and (B), respectively, and moving such subparagraphs 2 ems to the right; and #####
(C)by striking “ The Secretary ” and inserting the following: > > #### “(1) In general > > The Secretary” > ; ####
(2)by redesignating subsections
(b)through
(e)as paragraphs
(2)through (5), respectively, and moving such paragraphs 2 ems to the right; and ####
(3)by adding at the end the following: > > ### “(b) Statement of Patient Experience > > > #### “(1) In general > > Following the approval of an application that was submitted under section 505(b) of this Act or section 351(a) of the Public Health Service Act at least 180 days after the date of enactment of the 21st Century Cures Act, the Secretary shall make public a brief statement regarding the patient experience data and related information, if any, submitted and reviewed as part of such application. > > > #### “(2) Data and information > > The data and information referred to in paragraph
(1)are— > > > ##### “(A) > > patient experience data; > > > ##### “(B) > > information on patient-focused drug development tools; and > > > ##### “(C) > > other relevant information, as determined by the Secretary. > > > ### “(c) Patient Experience Data > > For purposes of this section, the term ‘patient experience data’ includes data that— > > > #### “(1) > > are collected by any persons (including patients, family members and caregivers of patients, patient advocacy organizations, disease research foundations, researchers, and drug manufacturers); and > > > #### “(2) > > are intended to provide information about patients’ experiences with a disease or condition, including— > > > ##### “(A) > > the impact of such disease or condition, or a related therapy, on patients’ lives; and > > > ##### “(B) > > patient preferences with respect to treatment of such disease or condition.” > .
Connectionstraces to 1
Traces to 1 document
Citation graph
cites case law
Sec. 3001
PATIENT EXPERIENCE DATA
Cites 1Cited by 0 across 0 sources