Types and Components of Investigational New Drugs (IND) Application

An Investigational New Drug (IND) application is a request for authorization from the FDA to administer an investigational drug or biological product to humans. This application must be authorized before the interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application (NDA) or Biologics License Application (BLA).

Types of IND

There are several types of INDs, including:

  1. Commercial IND: Submitted by companies whose ultimate goal is to obtain marketing approval for a new product.
  2. Research (Non-commercial) IND: Submitted by individual investigators or academic institutions for research purposes.
  3. Emergency Use IND: Allows the FDA to authorize the use of an experimental drug in an emergency situation that does not allow time for submission of an IND.
  4. Treatment IND: Allows the use of an experimental drug that shows promise in clinical testing for serious or immediately life-threatening conditions.

IND Components

The components of an IND application include:

  1. Administrative Information: Includes forms like Form FDA 1571 and Form FDA 1572.
  2. Clinical Protocols: Detailed plans for the clinical studies.
  3. Chemistry, Manufacturing, and Control (CMC) Information: Details about the drug’s composition, manufacturing process, and quality control measures.
  4. Pharmacology and Toxicology Information: Data from animal studies that support the safety of the drug for initial testing in humans.

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