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United States Code
U.S.C. Title 21-FOOD AND DRUGS
CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V-DRUGS AND DEVICES
Part E-General Provisions Relating to Drugs and Devices

21 U.S. Code § 360bbb-8b

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Use of clinical investigation data from outside the United States

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21 U.S. Code § 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.

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The United States Code on COSMOS is current through Public Law 118-34 (12/26/2023), except for Public Law 118-31.

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-4a Priority review to encourage treatments for agents that present national security threats
§360bbb-4b Medical countermeasure master files
§360bbb-5 Critical Path Public-Private Partnerships
§360bbb-5a Emerging technology program
§360bbb-6 Risk communication
§360bbb-7 Notification
§360bbb-8 Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments
§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

U.S. Code Popular Name Table

Popular Names

Americans with Disabilities Act 42 U.S.C. § 12101 et seq.

Anti-Kickback Statute 42 U.S.C. § 1320a–7b(b)

Clayton Act 15 U.S.C. § 12 et seq.

Clean Air Act 42 U.S.C. § 7401 et seq.

Commodity Exchange Act 7 U.S.C. § 1

Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) 42 U.S.C. § 9601 et seq.

Controlled Substances Act 21 U.S.C. § 801 et seq.

Emergency Medical Treatment and Labor Act (EMTALA) 42 U.S.C. § 1395dd

Fair Credit Reporting Act 15 U.S.C. § 1681

False Claims Act 31 U.S.C. § 3729 et seq.

Federal Food, Drug, and Cosmetic Act 21 U.S.C. § 301 et seq.

Federal Insecticide, Fungicide, and Rodenticide Act 7 U.S.C. § 136 et seq.

Federal Trade Commission Act 15 U.S.C. § 41 et seq.

Foreign corrupt Practices Act 15 U.S.C. § 78dd-1 et seq.

Fraud Enforcement and Recovery Act of 2009 (FERA) 18 U.S.C. § 27

Health Information Technology for Economic and Clinical Health Act (HITECH) 42 U.S.C. § 300jj et seq., 42 U.S.C. § 17901 et seq.

Health Insurance Portability and Accountability Act of 1996 (HIPAA) 42 U.S.C. § 201

National Environmental Policy Act (NEPA) 42 U.S.C. § 4321 et seq.

Patient Protection and Affordable Care Act 42 U.S.C. § 18001 et seq.

Physician Payments Sunshine Act 42 U.S.C. § 1320a–7h

Public Health Service Act 42 U.S.C. § 201 et seq.

Resource Conservation and Recovery Act (RCRA) 42 U.S.C. § 6901 et seq.

Robinson–Patman Act 15 U.S.C. § 13

Sarbanes-Oxley Act 15 U.S.C. § 7201 et seq.

Securities Act of 1933 15 U.S.C. § 77a et seq.

Sentencing Reform Act of 1984 18 U.S.C. § 3551 et seq.

Sherman Act 15 U.S.C. § 1 et seq.

Social Security Act 42 U.S.C. § 301 et seq.

Stark Law 42 U.S.C. § 1395nn

Toxic Substances Control Act 15 U.S.C. § 2601 et seq.

Use of clinical investigation data from outside the United States

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

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