(a) In generalThe 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 productIn this section, the term “medical product” means a drug, as defined in subsection (g) of section 321 of this title, 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 [42 U.S.C. 262(i)].
(c) Savings clauseNothing in this section shall alter the criteria for evaluating the safety or effectiveness of a medical product under this chapter or under the Public Health Service Act [42 U.S.C. 201 et seq.].
Structure US Code
CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V— DRUGS AND DEVICES
Part E— General Provisions Relating to Drugs and Devices
§ 360bbb. Expanded access to unapproved therapies and diagnostics
§ 360bbb–0. Expanded access policy required for investigational drugs
§ 360bbb–0a. Investigational drugs for use by eligible patients
§ 360bbb–1. Dispute resolution
§ 360bbb–2. Classification of products
§ 360bbb–3. Authorization for medical products for use in emergencies
§ 360bbb–3a. Emergency use of medical products
§ 360bbb–3b. Products held for emergency use
§ 360bbb–3c. Expedited development and review of medical products for emergency uses
§ 360bbb–4. Countermeasure development, review, and technical assistance
§ 360bbb–4b. Medical countermeasure master files
§ 360bbb–5. Critical Path Public-Private Partnerships
§ 360bbb–5a. Emerging technology program
§ 360bbb–6. Risk communication
§ 360bbb–8a. Optimizing global clinical trials
§ 360bbb–8b. Use of clinical investigation data from outside the United States
§ 360bbb–8c. Patient participation in medical product discussion
§ 360bbb–8d. Notification, nondistribution, and recall of controlled substances