United States of America
USNorth America
Regulatory Overview
United States of America is regulated by the Food and Drug Administration (FDA). The country has 2 documented regulatory pathways for accessing unapproved or unlicensed medicines, covering named patient programs, compassionate use schemes, and special access arrangements.
Regulatory Authority
Food and Drug Administration (FDA)
Regulatory Pathways (2)
FDA Emergency IND – USA 1 days
Emergency Investigational New Drug application for life-threatening situations requiring immediate treatment where there is no time to submit a formal IND. FDA may authorize treatment by telephone.
Application Form: Emergency IND Request (telephone/fax)
Legal Basis: 21 CFR 312.310
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: FDA Emergency IND Guidance
FDA program allowing patients with serious or immediately life-threatening conditions to access investigational drugs, biologics, or medical devices outside of clinical trials.
Application Form: FDA Form 3926 (Individual Patient IND)
Legal Basis: 21 CFR Part 312 Subpart I
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: FDA Expanded Access Guidance
Drugs Available (268)
United States of America
| ISO Code | US |
| Region | North America |
| Regulatory Authority | Food and Drug Administration (FDA) |
| Pathways | 2 documented |
| Drugs Available | 268 drug(s) |