The "treatment use" of investigational drugs usually occurs during FDA review of a new drug application (NDA). Added 6/22/2018 12:32:55 PM This answer has been confirmed as correct and helpful.
Full Answer
What are Treatment IND or treatment protocols and when are permitted?
There are four requirements that must be met before a treatment IND can be issued: 1) the drug is intended to treat a serious or immediately life-threatening disease; 2) there is no satisfactory alternative treatment available; 3) the drug is already under investigation, or trials have been completed; and 4) the trial ...Jul 12, 2018
What is a treatment IND?
The treatment IND is a mechanism for providing eligible subjects with investigational drugs for the treatment of serious and life-threatening illnesses for which there are no satisfactory alternative treatments.
When is a drug considered investigational?
A substance that has been tested in the laboratory and has been approved by the U.S. Food and Drug Administration (FDA) for testing in people. Clinical trials test how well investigational drugs work and whether they are safe to use.
What are the 3 phases an investigational drug goes through prior to submitting a new drug application?
Phase 1 studies (typically involve 20 to 80 people). Phase 2 studies (typically involve a few dozen to about 300 people). Phase 3 studies (typically involve several hundred to about 3,000 people). The pre-NDA period, just before a new drug application (NDA) is submitted.Aug 24, 2015