21 U.S.C. § 356g Standards For Regenerative Medicine and Regenerative Advanced Therapies

• Library: United States Statutes
• Edition: prefLabel,label,title,shortLabel
• Currency: Current through P.L. 118-19 (published on www.congress.gov on 10/06/2023)
• Citation: 21 U.S.C. § 356g

(a) In general

Not later than 2 years after December 13, 2016, the Secretary, in consultation with the National Institute of Standards and Technology and stakeholders (including regenerative medicine and advanced therapies manufacturers and clinical trial sponsors, contract manufacturers, academic institutions, practicing clinicians, regenerative medicine and advanced therapies industry organizations, and standard setting organizations), shall facilitate an effort to coordinate and prioritize the development of standards and consensus definition of terms, through a public process, to support, through regulatory predictability, the development, evaluation, and review of regenerative medicine therapies and regenerative advanced therapies, including with respect to the manufacturing processes and controls of such products.

(b) Activities

(1) In general

In carrying out this section, the Secretary shall continue to-

(A) identify opportunities to help advance the development of regenerative medicine therapies and regenerative advanced therapies;

(B) identify opportunities for the development of laboratory regulatory science research and documentary standards that the Secretary determines would help support the development, evaluation, and review of regenerative medicine therapies and regenerative advanced therapies through regulatory predictability; and

(C) work with stakeholders, such as those described in subsection (a), as appropriate, in the development of such standards.

(2) Regulations and guidance

Not later than 1 year after the development of standards as described in subsection (a), the Secretary shall review relevant regulations and guidance and, through a public process, update such regulations and guidance as the Secretary determines appropriate.

(c) Definitions

For purposes of this section, the terms "regenerative medicine therapy" and "regenerative advanced therapy" have the meanings given such terms in section 356(g) of this title.