What is IND treatment?
The treatment IND [21 CFR 312.34 and 312.35] 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.
What does IND mean in medical terms?
Investigational New Drug (IND) Application | FDA.
What is an IND approval?
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
When is an IND required?
An IND is required when a drug is involved in a clinical investigation that is not exempt from the regulations. The new guidance gives greater clarity to what is a 'drug', what is a 'clinical investigation' and which clinical investigations are exempt for the IND process.
What is the purpose of an IND?
The stated purpose of an IND is “to ensure that subjects will not face undue risk of harm” in a clinical investigation that involves the use of a drug. Hence, to authorize a drug study in humans, the FDA requires sufficient information to assess the safety of the intended research study.
What does IND stand for in nursing?
Abbreviation for investigational new drug.
Who approves IND application?
IRBs approve clinical trial protocol, informed consent/permission to all the participants and appropriate steps to prevent subjects from harm. 5. 5. If the FDA accepts the IND request within 30 days of submission, clinical testing of the new molecule on human may begin by the investigator.
How do I submit an IND to the FDA?
Submission of an Emergency IND Initial submission of an IND for emergency use: During normal business hours (i.e., 8:00 AM – 4:30 PM, Monday to Friday), contact CBER's Office of Communication, Outreach and Development of by phone at 240-402-8010 or 800-835-4709 ; or by email at: [email protected].
What is needed to maintain IND FDA?
An investigator is required to maintain adequate records of the disposition of the investigational drug, including dates, quantity, and use by subjects.
How do you verify an IND?
The IND number can be verified either by the IND number being identified in the associated sponsor protocol or by a letter from the FDA attached to the protocol confirming than an IND number has been obtained.
When Don't you need an IND?
The three most commonly occurring scenarios when clinical investigations may be exempted from the IND application requirements refer to certain limited situations of clinical investigations with approved marketed drugs, bioavailability or bioequivalence studies, or clinical investigations involving radioactive drugs ...