21 USC 356g - Standards for regenerative medicine and regenerative advanced therapies

U.S Code last checked for updates: May 05, 2024

§ 356g.

Standards for regenerative medicine and regenerative advanced therapies

(a)

In general

(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

(c)

Definitions

(June 25, 1938, ch. 675, § 506G, as added Pub. L. 114–255, div. A, title III, § 3036, Dec. 13, 2016, 130 Stat. 1104; amended Pub. L. 115–52, title IX, § 901(b), Aug. 18, 2017, 131 Stat. 1076.)

cite as: 21 USC 356g