FDA Proposes New Rule for Investigational New Drug Applications (IND)

FDA Proposes New Rule for Investigational New Drug Applications (IND)

Introduction:Investigational New Drug Applications (IND)

The FDA recently announced a proposal to change the current regulations for Investigational New Drug (IND) applications. The proposal includes two exemptions from IND requirements for clinical trials involving lawfully marketed foods (including functional foods and dietary supplements) and cosmetics when they are being studied for use as drugs.

In this blog, we will aim to unpack the key highlights of the FDA’s proposal on IND applications but if you wish to read the full proposal to learn about the clinical investigations, exemptions, and more click here.  If you want to submit a comment to the FDA after reading this proposal you can make comments until March 9th, 2023.

IND Application Background:

The purpose of an IND application is to help ensure the safety and rights of clinical trial participants are protected, as well as to ensure the quality of data is adequate to allow evaluation of the safety and effectiveness of a drug seeking marketing approval.

What is the proposal’s purpose?

  1. Firstly, to help speed up clinical trials involving legally marketed foods and cosmetics by removing them from the IND pathway.
  2. Additionally, to help incur cost-saving benefits by reducing the number of IND applications filed with the FDA.

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There were 2 exemptions proposed:

  1. Self-determined exemption: Food or cosmetics would be exempt from IND requirements if the following requirements were met:
  • The investigation is not intended to support a drug development plan, including a future IND or application for marketing approval.
  • The investigation is conducted in compliance with an institutional review, informed consent, and commercial distribution of investigational drugs:
    • Meeting with the requirements for institutional review in 21 CFR Part 56and the requirements for informed consent in 21 CFR Part 50; and
    • Meeting with the requirements of 7.
  • The route of administration is the same as that of the lawfully marketed product.
  • The investigation meets the following participant health, safety, and welfare requirements:
    • No participants below 12 months.
    • No pregnant or lactating mothers.
    • No participants with compromised immune systems.
    • Does not restrict participants from taking a prescribed therapeutic.
    • Does not increase risk beyond routine physical or psychological evaluations or standard of care procedures.
    • The product is being used in a way that is consistent with its labelled conditions of use.
    • No other product taken by or used to treat subjects during the investigation would significantly increase the risks (or decrease acceptability of the risks) encountered in the investigation.
    • There were no participants with weakened immune systems.
    • Participants are not prohibited from taking a prescribed therapeutic.
    • Increases risk in addition to routine physical or psychological evaluations or standard of care procedures.
    • The product is being used in accordance with its labelled conditions of use.
    • No other product taken by or used to treat subjects during the investigation would significantly increase (or decrease acceptability of) the risks encountered.
  1. FDA-determined exemption: While some products may not meet all the safety-related eligibility requirements for the self-determined exemption, the FDA may conclude that the study does not pose a significant risk to participants’ health, safety, or welfare. To qualify for the FDA-approved exemption, products must meet the following criteria:

*The product must be legally marketed as a Food or Cosmetic in the United States.

  • The FDA would require a copy of the study protocol, which would include the following information: design and duration.
  • Endpoints that have been proposed.
  • The study population, as well as the inclusion and exclusion criteria.
  • Description of the investigational product, including all ingredients, formulation, and labelling information.
  • The dosage form and regimen.
  • Administration path.
  • Examine the procedures.
  • In the event of an adverse/serious adverse event, the protocol is altered.
  • Provide evidence that the investigational product does not pose a significant risk to:
  • Participants must be less than 12 months old, pregnant, or lactating.
  • Participants with weakened immune systems or who suffer from serious or life-threatening diseases or conditions.
  • If participation necessitates the discontinuation of therapy or treatment prescribed by a healthcare provider.
  • If the study procedures put participants in greater danger than they would normally face during routine physical or psychological evaluations or standard-of-care procedures.
  • If the proposed conditions of use of the product in the investigation differ from the labelled or usual conditions of use of the product.
  • If the investigational product is used in conjunction with other medications or treatments that a subject is taking or receiving,
  • If the investigational product is being used concurrently with other products that a subject is taking or being treated with, either as part of the study or as prescribed or recommended by a healthcare provider outside the study.

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