Sec. 201. Expanded access policy
305 words·~1 min read·
/bill/114/s/1883/is/section-201A 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 publicly 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. A manufacturer or distributor may satisfy the requirement of the preceding sentence by posting such policy as generally applicable to all of such manufacturer’s of distributor’s investigational drugs.
A policy described in subsection
(a)shall include making publicly available— 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 consider or use to approve such requests; and the length of time the manufacturer or distributor anticipates will be necessary to acknowledge receipt of such requests. 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. A manufacturer or distributor that has made a policy publicly available as required by this section may revise the policy 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 days after the date of enactment of the Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2015 ; 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 new drug. .
Connectionstraces to 1
Traces to 1 document
Citation graph
cites case law
Sec. 201
Expanded access policy
Cites 1Cited by 0 across 0 sources