21 U.S.C. § 360bbb-8b — Use of clinical investigation data from outside the United States

(a) In general In determining whether to approve, license, or clear a drug , biological product, or device pursuant to an application submitted under this subchapter, 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, biological product, 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, biological product, or device pursuant to an application submitted under this subchapter, the Secretary shall provide written notice to the sponsor of the application of such finding and include the rationale for such finding. (June 25, 1938, ch. 675, § 569B, as added Pub. L. 112–144, title XI, § 1123 , July 9, 2012 , 126 Stat. 1113 ; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(Q) , Dec. 13, 2016 , 130 Stat. 1155 .) Editorial Notes Amendments 2016— Pub. L. 114–255 substituted “drug, biological product, or device” for “drug or device” wherever appearing. CFR Title Parts 21 807 , 812 , 814

Related documents

• 21 U.S.C. § 360bbb-0 — Expanded access policy required for investigational drugs#577310
• Regression Discontinuity Design to Evaluate of Drotrecogin Alpha Effectiveness#1138798
• Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration#7375
• 25 U.S.C. § 1621l — Patient travel costs#582475
• Post-COVID-19 Monitoring in Routine Health Insurance Data#916453