21 U.S.C. § 360bbb-5a - U.S. Code - Unannotated Title 21. Food and Drugs § 360bbb-5a. Emerging technology program

(A) facilitate and increase communication between public and private entities, consortia, and individuals with respect to innovative drug product design and manufacturing;

(B) solicit information regarding, and conduct or support research on, innovative approaches to drug product design and manufacturing;

(C) convene meetings with representatives of industry, academia, other Federal agencies, international agencies, and other interested persons, as appropriate;

(D) convene working groups to support drug product design and manufacturing research and development;

(E) support education and training for regulatory staff and scientists related to innovative approaches to drug product design and manufacturing;

(F) advance regulatory science related to the development and review of innovative approaches to drug product design and manufacturing;

(G) convene or participate in working groups to support the harmonization of international regulatory requirements related to innovative approaches to drug product design and manufacturing; and

(H) award grants or contracts to carry out or support the program under paragraph (1).

(A) in such form and manner as the Secretary may require; and

(B) containing such information as the Secretary may require, including a description of--

(A) any regulatory requirements related to the development or review of technologies related to innovative approaches to drug product design and manufacturing, including updates and improvements to such technologies after product approval; and

(B) data that can be used to demonstrate the identity, safety, purity, and potency of drugs manufactured using such technologies.