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IND Draft Guidance Document

IND Draft Guidance Document

IND Draft Guidance Document

Recently the FDA came out with a draft guidance document concerning IND (Investigational New Drugs). Here is some of that draft document.

Objective

  • To assist clinical investigators, sponsors, and sponsor-investigators in determining whether human research studies must be conducted under an investigational new drug application (IND)
  • When an IND is required, specific situations in which an IND is not required, and a range of issues that, in FDA’s experience, have been the source of confusion or misperceptions about the application of the IND regulations

A clinical investigation of a drug is exempt from the IND requirements if all of the criteria for an exemption in § 312.2(b) is met:

  • The drug product is lawfully marketed in the United States
  • There is no intent to report the investigation to FDA as a well-controlled study in support of a new indication and no intent to use it to support any other significant change in the labeling of the drug
  • In the case of a prescription drug, the investigation is not intended to support a significant change in the advertising for the drug
  • The investigation does not involve a route of administration, dose, patient population, or other factor that significantly increases the risk (or decreases the acceptability of the risk) associated with the use of the drug product
  • The investigation is conducted in compliance with the requirements for review by an IRB and with the requirements for informed consent
  • The investigation is conducted in compliance with the requirements of 312.7 i.e., the investigation is not intended to promote or commercialize the drug product.
  •  A clinical investigation of a drug is exempt from the IND requirements if all of the criteria for an exemption in § 312.2(b) is met:
  • The drug product is lawfully marketed in the United States.
  • There is no intent to report the investigation to FDA as a well-controlled study in support of a new indication and no intent to use it to support any other significant change in the labeling of the drug.
  • In the case of a prescription drug, the investigation is not intended to support a significant change in the advertising for the drug.
  • The investigation does not involve a route of administration, dose, patient population, or other factor that significantly increases the risk (or decreases the acceptability of the risk) associated with the use of the drug product.
  • The investigation is conducted in compliance with the requirements for review by an IRB and with the requirements for informed consent.
  • The investigation is conducted in compliance with the requirements of 312.7 i.e., the investigation is not intended to promote or commercialize the drug product.

FDA regulations (21 CFR 361.1) describe conditions under which radioactive drugs (drugs 288 containing unstable isotopes) can be used for certain research without an IND because they are generally recognized as safe and effective for those uses. These regulations apply to radioactive versions of both approved and unapproved drugs.

FDA does not intend to object to clinical investigations using cold isotopes of unapproved drugs being conducted without an IND, provided the following conditions are met 306 (the conditions are based on the criteria for studies using radio labeled drugs (see 21 CFR 307 361.1)

  • The research is intended to obtain basic information regarding the metabolism (including kinetics, distribution, and localization) of a drug labeled with a cold isotope or regarding human physiology, pathophysiology, or biochemistry.
  • The research is not intended for immediate therapeutic, diagnostic, or preventive benefit  to the study subject.
  • The dose to be administered is known not to cause any clinically detectable pharmacologic effect in humans based on clinical data from published literature or other valid human studies.
  • The quality of the cold isotope meets relevant quality standards.
  •  The research is reviewed and approved by an IRB (21 CFR part 56) and informed 323 consent is obtained from the research subjects (21 CFR part 50).

A BA/BE study in humans does not require an IND if all of the following conditions are met: 

  • The drug product does not contain a new chemical entity (21 CFR 314.108), is not radioactively labeled, and is not cytotoxic.
  • The dose (single dose or total daily dose) does not exceed the dose specified in the labeling of the approved version of the drug product.
  • The investigation is conducted in compliance with the requirements for review by an IRB (21 CFR part 56) and the requirements for informed consent (21 CFR part 50).
  •  The sponsor meets the requirements for retention of test article samples.


IFor more information on this draft document and/or would like to further discuss these areas of concern, please email us at info@mdiconsultants.com  Ref: IND draft doc