Under current Federal law; any manufacturer wanting to market a drug in the US has to subject the drug to an approved marketing application before its transportation and/or distribution in the different States in the US. Since there is a strong possibility that the sponsor of a clinical trial may want to ship the investigational drug to clinical investigators across several states, the sponsor would ideally look to get exempted from this legal requirement. The mechanism through which this exemption issues to the sponsor from the FDA is the Investigational New Drug Applications in the USA.
That is, an Investigational New Drug Application is a request that the sponsor makes with the FDA for authorization to administer a biological product or an investigational drug to humans. This authorization needs to be secured before the product goes through interstate shipment. It also needs to happen before a drug that is not the same as an approved New Drug Application or Biologics/Product License Application is administered.
The logic behind filing Investigational New Drug Application
The entire idea behind filing an Investigational New Drug Application is to ensure the drug’s safety for use in humans. This leads to the embarking of steps for its commercialization. The Investigational New Drug Application is often the first step that paves the way for further actions such as data collection to reinforce its safety factor. An Investigational New Drug Application is a sort of guarantee that when the drug that is at this stage of studies is administered on humans; they do not carry risks.
When does the FDA’s role begin?
The FDA’s role in the Investigational New Drug Application begins at the time when the sponsor wants to test the effect on humans of molecules that is identified earlier.
Types of INDs
There are three types of Investigational New Drug Applications:
What should an Investigational New Drug Application contain?
An Investigational New Drug Application should contain the following:
- Studies done to test animal pharmacology and toxicology
- Information concerning manufacturing
- Information about the Investigational New Drug Application’s clinical protocols and investigator