Investigational New Drug

The laws prohibit administration of products in humans that have not been approved by the FDA. IND application is filled in USFDA after the necessary safety and toxicological preclinical study in animals. IND application is filed to conduct human clinical Trial in US.  

Under the Food, Drug, and Cosmetic Act of 1938, sponsor require to file IND application before any unapproved medicine is transported or distributed across state lines in US.

Sec. 312.23 IND content and format

• Cover sheet
• A table of contents
• Introductory statement and general investigational plan
• Investigator's brochure
• Protocols
• Chemistry, manufacturing, and control information
• Pharmacology and toxicology information
• Previous human experience with the investigational drug
• Additional information

The FDA has 30 days to review IND application to determine whether the proposed trial appears reasonably safe to proceed or to impose clinical hold if it does not. If FDA does not raise any issue with the applicant within 30 days from receipt of the application, sponsor may proceed for the clinical trials.

At any time a sponsor may withdraw an effective IND without prejudice. If an IND is withdrawn, FDA shall be so notified, all clinical investigations conducted under the IND shall be ended. There are various types of IND filled with USFDA.

Types of IND:

1. Investigator/Research IND: An Investigator IND is submitted by a physician who both initiates and conducts an investigation, and under whose supervision investigational drug is administered or dispensed. A physician might submit a research IND to study an unapproved drug, or an approved product for a new indication or in a new patient population.

2. Emergency IND: Need for an investigational drug may arise in an emergency situation that does not allow time for submission of an IND. In such a case, FDA may authorize shipment of the drug for a specified use in advance of submission of an IND. A request for such authorization may be transmitted to. It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist. 

3. Treatment IND: A drug that is not approved for marketing and may be under clinical trials for a serious or immediately life-threatening disease condition in patients for whom no comparable or satisfactory alternative drug or other therapy is available. During the clinical investigation of the drug, it may be appropriate to use the drug in the treatment of patients, in accordance with a treatment protocol or treatment IND. In the case of an immediately life-threatening disease, a drug may be made available for treatment use earlier than Phase 3, but ordinarily not earlier than Phase 2.