Sec. 3032. Expanded access policy
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/bill/114/hr/34/enr/section-3032·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 561 ( 21 U.S.C. 360bbb ) the following: The manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make available the policy of the manufacturer or distributor on evaluating and responding to requests submitted under section 561(b) for provision of such a drug. The policies under subsection
(a)shall be made public and readily available, such as by posting such policies on a publicly available Internet website. Such policies may be generally applicable to all investigational drugs of such manufacturer or distributor. A policy described in subsection
(a)shall include— contact information for the manufacturer or distributor to facilitate communication about requests described in subsection (a); procedures for making such requests; the general criteria the manufacturer or distributor will use to evaluate such requests for individual patients, and for responses to such requests; the length of time the manufacturer or distributor anticipates will be necessary to acknowledge receipt of such requests; and a hyperlink or other reference to the clinical trial record containing information about the expanded access for such drug that is required under section 402(j)(2)(A)(ii)(II)(gg) of the Public Health Service Act. The posting of policies by manufacturers and distributors under subsection
(a)shall not serve as a guarantee of access to any specific investigational drug by any individual patient. Nothing in this section shall prevent a manufacturer or distributor from revising a policy required under this section at any time. This section shall apply to a manufacturer or distributor with respect to an investigational drug beginning on the later of— the date that is 60 calendar days after the date of enactment of the 21st Century Cures Act ; or the first initiation of a phase 2 or phase 3 study (as such terms are defined in section 312.21(b) and
(c)of title 21, Code of Federal Regulations (or any successor regulations)) with respect to such investigational drug. .
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Sec. 3032
Expanded access policy
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