View all text of Subpart 1 [§ 262 - § 263-1]
§ 263–1. Education on biological products
(a) Internet website
(1) In general
(2) Content
Educational materials provided under paragraph (1) may include—
(A) explanations of key statutory and regulatory terms, including “biosimilar” and “interchangeable”, and clarification regarding the use of interchangeable biosimilar biological products;
(B) information related to development programs for biological products, including biosimilar biological products and interchangeable biosimilar biological products and relevant clinical considerations for prescribers, which may include, as appropriate and applicable, information related to the comparability of such biological products;
(C) an explanation of the process for reporting adverse events for biological products, including biosimilar biological products and interchangeable biosimilar biological products; and
(D) an explanation of the relationship between biosimilar biological products and interchangeable biosimilar biological products licensed under section 262(k) of this title and reference products (as defined in section 262(i) of this title), including the standards for review and licensing of each such type of biological product.
(3) Format
The educational materials provided under paragraph (1) may be—
(A) in formats such as webinars, continuing education modules, videos, fact sheets, infographics, stakeholder toolkits, or other formats as appropriate and applicable; and
(B) tailored for the unique needs of health care providers, patients, caregivers, and other audiences, as the Secretary determines appropriate.
(4) Other information
In addition to the information described in paragraph (2), the Secretary shall continue to publish—
(A) the action package of each biological product licensed under subsection (a) or (k) of section 262 of this title; or
(B) the summary review of each biological product licensed under subsection (a) or (k) of section 262 of this title.
(5) Confidential and trade secret information
(b) Continuing education
(July 1, 1944, ch. 373, title III, § 352A, as added Pub. L. 117–8, § 2, Apr. 23, 2021, 135 Stat. 254.)