When do I need an IND ?. FDA Guidance for Industry – Investigation New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without and IND Procedural Draft for Public Comment October 2010. Investigational New Drug – New?.
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FDA Guidance for Industry – Investigation New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without and IND
Procedural Draft for Public Comment
The FDA uses the filing requirements of the IND as the primary mechanisms for ensuring the safety of research subjects.
The term IND can be misinterpreted, leading researchers to conclude that if the drug they are studying is already approved by the FDA, it is not a “new” drug needing a IND.
The FDA approves a drug as safe with specifications (these indications are spelled out in the Investigational Brochure, labeling, package insert or in the PDR):
“articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease….” and articles (other than food) intended to affect the structure or any function of the body of man or other animals”
Includes: Biologics, compounds administered to healthy subjects to blunt or provoke a physiologic response (vasopressin) or to study the mechanism of action or metabolism of a drug (contrast agents, markers).
Dietary Supplements that affect the structure or function of the body and not intended for a therapeutic purpose is not a drug.
“In contrast, use of a licensed drug in the course of medical practice involves the use in an individual patient where the primary intent is to treat the patient but not to study the safety or effectiveness of a drug is any systematic way.”
Otherwise exempt categories
There are 3:
2.Bioavailablity or Bioequivalence Studies in Humans
3.Radioactive Drugs for Certain uses
Clinical investigation of a drug is exempt if all of the following criteria are met:
significantly increases the risk (or decreases the acceptability of the risk)
associated with the use of the drug product.
“ not intended to require that a drug be used in exactly the same dosage form, level, and patient population described in the marketed labeling….but only permit changes…. that do not increase the risk to greater than the risk presented by the use of the product in conformance with its marketed label.”
Low risk modifications : blinding a product by changing its color, scoring or capsule size…
Greater risk modifications; Products that are sensitive to conditions in the environment, may create changes to formulation…. or primary packaging. (examples)
No comprehensive guide - may request consultation with FDA (formal or informal)
Risk assessment of a marketed drug:
Oncology setting has been separated out:
IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer
PI sponsors may have no intent utilize study results for changing labeling or advertising but the research results may have the potential to do so….
Example: Coumadin® is very unstable in high humidity, which is why the pills are coated. Crushing of these caplets can change them chemically and result in unanticipated safety risks and a lack of efficacy.
Charging for investigational products under an IND
Old rule- rarely permitted, required FDA written permission
New rule November 2009 – covers charging for investigational drugs in clinical trials and expanded access use.
(FDA has not changed it’s letters to reflect this change)
Take home message – PI/ sponsor/ investigator researching an approved drug for unapproved use can have subject obtain drug and bill third party.
IND Decision Support tool by the University of Penn
MMC HRPP Web Site:
“,,,[an] experiment in which a drug is administered or dispensed to, or used involving, one or more human subject.”
“For the purposes of [the IND regs] an experiment is, any use of a drug [approved or not] except for the use of a marketed drug in the course of medical practice.”