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U.S Code last checked for updates: Nov 22, 2024
All Titles
Title 21
Chapter 9
Subchapter V
Part E
§ 360bbb-8b. Use of clinical inv...
§ 360bbb-8d. Notification, nondi...
§ 360bbb-8b. Use of clinical inv...
§ 360bbb-8d. Notification, nondi...
U.S. Code
Notes
§ 360bbb–8c.
Patient participation in medical product discussion
(a)
Patient engagement in drugs and devices
(1)
In general
The Secretary shall develop and implement strategies to solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussions, including by—
(A)
fostering participation of a patient representative who may serve as a special government employee in appropriate agency meetings with medical product sponsors and investigators; and
(B)
exploring means to provide for identification of patient representatives who do not have any, or have minimal, financial interests in the medical products industry.
(2)
Protection of proprietary information
(3)
Other consultation
(4)
No right or obligation
(5)
Financial interest
(b)
Statement of patient experience
(1)
In general
(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 (including physical and psychosocial impacts) of such disease or condition, or a related therapy or clinical investigation on patients’ lives; and
(B)
patient preferences with respect to treatment of such disease or condition.
(
June 25, 1938, ch. 675, § 569C
, as added
Pub. L. 112–144, title XI, § 1137
,
July 9, 2012
,
126 Stat. 1124
; amended
Pub. L. 114–255, div. A, title III, § 3001
,
Dec. 13, 2016
,
130 Stat. 1083
;
Pub. L. 115–52, title VI, § 605
,
Aug. 18, 2017
,
131 Stat. 1048
.)
cite as:
21 USC 360bbb-8c
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