An investigational new drug (IND) refers to a new drug or biological product that is being tested in clinical trials. This term also includes biological products used for diagnostic purposes in laboratory settings. In the context of drug regulation, the terms "investigational drug" and "investigational new drug" are considered synonymous.
The term investigational new drug is primarily used in the field of pharmaceutical law and regulatory compliance. It is relevant in the context of drug development and clinical research. Legal practitioners may encounter this term when dealing with:
Individuals or organizations may manage related processes using legal templates available through resources like US Legal Forms, which provide guidance on necessary documentation.
Here are a couple of examples of abatement:
Example 1: A pharmaceutical company develops a new cancer treatment and submits an IND application to the FDA to begin clinical trials. This drug is classified as an investigational new drug during the trial phase.
Example 2: A laboratory uses a new biological product for diagnostic testing in vitro. This product also qualifies as an investigational new drug under FDA regulations.
The primary regulation governing investigational new drugs is found in Title 21 of the Code of Federal Regulations, specifically:
This regulation outlines the requirements for submitting an IND application and the responsibilities of sponsors during clinical investigations.
| Term | Definition | Key Difference |
|---|---|---|
| Investigational New Drug | A drug being tested in clinical trials. | Specifically refers to drugs under investigation. |
| New Drug Application (NDA) | A formal proposal for the FDA to approve a new drug. | NDA is for drugs that have completed clinical trials, while IND is for those still in trials. |
| Clinical Trial | A research study to test the efficacy and safety of a drug. | Clinical trials involve testing investigational new drugs. |
If you are involved in the development or testing of a new drug, ensure compliance with FDA regulations regarding investigational new drugs. You may want to:
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| Attribute | Details |
|---|---|
| Typical Fees | Varies based on the application process and legal assistance. |
| Jurisdiction | Federal (FDA regulations) and applicable state laws. |
| Possible Penalties | Non-compliance can lead to fines, delays in approval, or legal action. |