Investigational New Drug

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 cleared, the candidate drug usually enters a Phase 1 clinical trial. Regulations are primarily at 21 C.F.R. 312.

Criteria for application

An IND is required for a clinical study if it is intended to support a:

Application contents

The IND application must contain information in three broad areas:[1]

An IND must also include an Investigator's Brochure which is a document intended to educate the trial investigators of the significant facts about the trial drug they need to know to conduct their clinical trial with the least hazard to the subjects or patients who will be enrolled.

IND types

Timeline comparing "standard" drug approval procedure to several exceptional cases

There are three IND types:[1]

Additional regulations

Noteworthy examples

The FDA runs a medical marijuana IND program (the Compassionate Investigational New Drug program). It stopped accepting new patients in 1992 after public health authorities concluded there was no scientific value to it, and due to President George H.W. Bush administration's desire to "get tough on crime and drugs." As of 2011, four patients continue to receive cannabis from the government under the program.[2]

See also


  1. 1 2 "Investigational New Drug (IND) Application". FDA. Retrieved 7 March 2013.
  2. AP (September 27, 2011). Associated Press News Missing or empty |title= (help)

Further reading

External links

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