“What is an Investigational New Drug (IND) Application and When is it Required?”
What is an Investigational New Drug (IND) Application and When is it Required?”
In this article you are going to learn about IND and its types and when an IND is required. Generally, in the US to conduct clinical trials i.e. for the administration of investigational drug to humans IND is required, so IND is an application submitted to the FDA to conduct clinical trials using the investigational drug or biologic.
The Purpose of the IND application is to ensure the drug is safe for human use and also to access the study testing plan. IND is an important step in the drug development process. Along with the FDA, an IND application is also reviewed by the Institutional Review Board whose primary goal is to protect or work for the rights and welfare of humans.
Before the conduct of clinical trials, one has to submit an IND application to the FDA. Once an IND is submitted, the FDA has 30 days to review the application, if any deficiencies/ objections are present in the application FDA seeks information from the applicant, this is called a clinical hold.
During the review period, the FDA evaluates the application for safety and the potential risks of the study that the applicant wants to conduct. If no major deficiencies are found after 30 days applicant can start the clinical trials, but most companies wait for the No Objection letter, this is because, if the FDA wants more information after 30 days when the company already started trials, it will be associated with more cost.
When an IND is submitted
- An IND application must be submitted before starting any clinical trials involving human subjects.
- When testing a new chemical entity or biological product in humans.
- For a new indication, dosage form, or patient population for an already approved drug
- Types of Investigational New Drug Applications
- These include
- Commercial IND
- Investigator IND
- Emergency Use IND
Form for IND application: FDA form 1571 is the primary form used for IND application along with this statement of investigator (FDA Form 1572) and investigators brochure, protocol of the clinical study, and informed consent forms are the supporting documents to be submitted at the time of IND application.