OPTIMIZING GLOBAL CLINICAL TRIALS.

SEC. 1123. OPTIMIZING GLOBAL CLINICAL TRIALS. Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as amended by section 903 of this Act, is further amended by adding at the end the following: “SEC. 569A. OPTIMIZING GLOBAL CLINICAL TRIALS “(a) In General. The Secretary shall— “(1) work with other regulatory authorities of similar standing, medical research companies, and international organizations to foster and encourage uniform, scientifically driven clinical trial standards with respect to medical products around the world; and “(2) enhance the commitment to provide consistent parallel scientific advice to manufacturers seeking simultaneous global development of new medical products in order to— “(A) enhance medical product development; “(B) facilitate the use of foreign data; and “(C) minimize the need to conduct duplicative clinical studies, preclinical studies, or nonclinical studies. “(b) Medical Product. In this section, the term ‘medical product’ means a drug, as defined in subsection (g) of section 201, a device, as defined in subsection (h) of such section, or a biological product, as defined in section 351(i) of the Public Health Service Act. “(c) Savings Clause. Nothing in this section shall alter the criteria for evaluating the safety or effectiveness of a medical product under this Act. “SEC. 569B. USE OF CLINICAL INVESTIGATION DATA FROM OUTSIDE THE UNITED STATES “(a) In General. In determining whether to approve, license, or clear a drug or device pursuant to an application submitted under this chapter, the Secretary shall accept data from clinical investigations conducted outside of the United States, including the European Union, if the applicant demonstrates that such data are adequate under applicable standards to support approval, licensure, or clearance of the drug or device in the United States. “(b) Notice to Sponsor. If the Secretary finds under subsection (a) that the data from clinical investigations conducted outside the United States, including in the European Union, are inadequate for the purpose of making a determination on approval, clearance, or licensure of a drug or device pursuant to an application submitted under this chapter, the Secretary shall provide written notice to the sponsor of the application of such finding and include the rationale for such finding.” .