21 U.S.C. § 360bbb–8a — Optimizing global clinical trials

(a) In general The Secretary must (1) work with foreign regulatory authorities of similar standing, medical research companies, and international organizations, to encourage uniform, science-based clinical trial standards for medical products around the world; and (2) strengthen the FDA's commitment to give manufacturers consistent, parallel scientific advice when they're developing a new medical product globally at the same time, in order to (A) improve medical product development, (B) make it easier to use data collected abroad, and (C) cut down on the need for duplicate clinical, preclinical, or nonclinical studies. (b) Medical product Here, "medical product" means a drug, as subsection (g) of section 321 of this title defines it, a device, as subsection (h) of that section defines it, or a biological product, as section 351(i) of the Public Health Service Act defines it. (c) Savings clause Nothing in this section changes the standards the FDA uses to judge whether a medical product is safe or effective under this chapter or the Public Health Service Act.