21 U.S. Code § 360bbb–8c - Patient participation in medical product discussion
Nothing in this section shall be construed to alter the protections offered by laws, regulations, or policies governing disclosure of confidential commercial or trade secret information and any other information exempt from disclosure pursuant to section 552(b) of title 5 as such laws, regulations, or policies would apply to consultation with individuals and organizations prior to July 9, 2012.
Nothing in this section shall be construed to limit the ability of the Secretary to consult with individuals and organizations as authorized prior to July 9, 2012.
Nothing in this section shall be construed to create a legal right for a consultation on any matter or require the Secretary to meet with any particular expert or stakeholder. Nothing in this section shall be construed to alter agreed upon goals and procedures identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012. Nothing in this section is intended to increase the number of review cycles as in effect before July 9, 2012.
Following the approval of an application that was submitted under section 355(b) of this title or section 262(a) of title 42 at least 180 days after December 13, 2016, 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.
2016—Subsec. (a). Pub. L. 114–255, § 3001(1), (2), substituted “Patient engagement in drugs and devices” for “In general” in subsec. heading, designated existing provisions as par. (1) and inserted par. heading, redesignated former pars. (1) and (2) as subpars. (A) and (B), respectively, of par. (1), redesignated subsecs. (b) to (e) as as pars. (2) to (5), respectively, and realigned margins.
Subsecs. (b), (c). Pub. L. 114–255, § 3001(3), added subsecs. (b) and (c). Former subsecs. (b) and (c) redesignated pars. (2) and (3), respectively, of subsec. (a).
Subsecs. (d), (e). Pub. L. 114–255, § 3001(2), redesignated subsecs. (d) and (e) as pars. (4) and (5), respectively, of subsec. (a).
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