Investigational new drug
From Wikipedia, the free encyclopedia
U.S. drug regulation
Prescription drugs
Over-the-counter drugs
Law
Federal Food, Drug, and Cosmetic Act
Comprehensive Drug Abuse Prevention and Control Act of 1970
Controlled Substances Act
Prescription Drug Marketing Act
Drug Price Competition and Patent Term Restoration Act
Hatch-Waxman exemption
Government agencies
United States Department of Health and Human Services
Food and Drug Administration
Drug Enforcement Administration
National Institutes of Health
Center for Drug Evaluation and Research
Process
Drug development
New drug application
Investigational new drug
Clinical trial (Phase I, II, III, IV)
Randomized controlled trial
Pharmacovigilance
Abbreviated New Drug Application
Fast track approval
International coordination
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
Uppsala Monitoring Centre
World Health Organization
Council for International Organizations of Medical Sciences
Single Convention on Narcotic Drugs
Non-governmental organizations
Institute of Medicine
Research on Adverse Drug events And Reports
This box: view " talk " edit
The United States Food and Drug Administration's investigational new drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. The FDA reviews the IND application for safety to assure that research subjects will not be subjected to unreasonable risk. If the application is approved, the candidate drug usually enters a Phase 1 clinical trial.
