You are here: Home Managing Your ... Clinical Trials ... Clinical Trial ... IND Exempt Clinical ...
Information For Living With: Choose condition »
Information about all aspects of finances affected by a serious health condition. Includes income sources such as work, investments, and private and government disability programs, and expenses such as medical bills, and how to deal with financial problems.
Information about all aspects of health care from choosing a doctor and treatment, staying safe in a hospital, to end of life care. Includes how to obtain, choose and maximize health insurance policies.
Answers to your practical questions such as how to travel safely despite your health condition, how to avoid getting infected by a pet, and what to say or not say to an insurance company.

Clinical Trial Phases

IND Exempt Clinical Trials

« Previous

6/6

“IND Exempt Clinical Trials” are a slight variation on approved drugs. For example, the trial tests a change in scheduling or dosage. These trials are not really Phase IV, but are similar.

IND Exempt Clinical Trials are usually initiated by an investigator, not a pharmaceutical company.

The FDA doesn’t review these trials. It sets the criteria for IND Exempt Clinical Trials in regulations. If a trial wants to go outside the regulations, it requires FDA review.


Please share how this information is useful to you. 0 Comments

 

Post a Comment Have something to add to this topic? Contact Us.

Characters remaining:

  • Allowed markup: <a> <i> <b> <em> <u> <s> <strong> <code> <pre> <p>
    All other tags will be stripped.