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20 results 360bbb-8c
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Exact match Title 21 Title 21 / Chapter 9 FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices / Section 360bbb–8c

21 U.S.C. § 360bbb–8c

Patient participation in medical product discussion

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Exact citation match for 21 USC § 360BBB-8C

Title 21 Title 21 / Section 355

21 U.S.C. § 355

New drugs

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

New drugs

Title 21 Title 21 / Section 360bbb

21 U.S.C. § 360bbb

Expanded access to unapproved therapies and diagnostics

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Expanded access to unapproved therapies and diagnostics

Title 21 Title 21 / Section 360bbb–0

21 U.S.C. § 360bbb–0

Expanded access policy required for investigational drugs

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Expanded access policy required for investigational drugs

Title 21 Title 21 / Section 360bbb–0a

21 U.S.C. § 360bbb–0a

Investigational drugs for use by eligible patients

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Investigational drugs for use by eligible patients

Title 21 Title 21 / Section 360bbb–1

21 U.S.C. § 360bbb–1

Dispute resolution

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Dispute resolution

Title 21 Title 21 / Section 360bbb–2

21 U.S.C. § 360bbb–2

Classification of products

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Classification of products

Title 21 Title 21 / Section 360bbb–3

21 U.S.C. § 360bbb–3

Authorization for medical products for use in emergencies

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Authorization for medical products for use in emergencies

Title 21 Title 21 / Section 360bbb–3a

21 U.S.C. § 360bbb–3a

Emergency use of medical products

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Emergency use of medical products

Title 21 Title 21 / Section 360bbb–3b

21 U.S.C. § 360bbb–3b

Products held for emergency use

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Products held for emergency use

Title 21 Title 21 / Section 360bbb–3c

21 U.S.C. § 360bbb–3c

Expedited development and review of medical products for emergency uses

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Expedited development and review of medical products for emergency uses

Title 21 Title 21 / Section 360bbb–4

21 U.S.C. § 360bbb–4

Countermeasure development, review, and technical assistance

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Countermeasure development, review, and technical assistance

Title 21 Title 21 / Section 360bbb–4a

21 U.S.C. § 360bbb–4a

Priority review to encourage treatments for agents that present national security threats

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Priority review to encourage treatments for agents that present national security threats

Title 21 Title 21 / Section 360bbb–4b

21 U.S.C. § 360bbb–4b

Medical countermeasure master files

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Medical countermeasure master files

Title 21 Title 21 / Section 360bbb–5

21 U.S.C. § 360bbb–5

Critical Path Public-Private Partnerships

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Critical Path Public-Private Partnerships

Title 21 Title 21 / Section 360bbb–5a

21 U.S.C. § 360bbb–5a

Emerging technology program

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Emerging technology program

Title 21 Title 21 / Section 360bbb–6

21 U.S.C. § 360bbb–6

Risk communication

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Risk communication

Title 21 Title 21 / Section 360bbb–7

21 U.S.C. § 360bbb–7

Notification

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Notification

Title 21 Title 21 / Section 360bbb–8

21 U.S.C. § 360bbb–8

Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments

Title 21 Title 21 / Section 360bbb–8a

21 U.S.C. § 360bbb–8a

Optimizing global clinical trials

Subchapter V DRUGS AND DEVICES / Part E General Provisions Relating to Drugs and Devices

Optimizing global clinical trials