FDA's role in the development of a new drug begins when the drug's sponsor (usually the manufacturer or potential marketer), having screened the new molecule for pharmacological activity and acute toxicity potential in animals, wants to test its diagnostic or therapeutic potential in humans.
At that point, the molecule changes in legal status under the Federal Food, Drug, and Cosmetic Act and becomes a new drug subject to specific requirements of the drug regulatory system.
FDA has two primary objectives in reviewing an IND: (1) to assure the safety and rights of subjects in all phases of an investigation and (2) in phases 2 and 3, to help assure that the quality of the scientific evaluation of the drug is adequate to permit an evaluation of the drug's effectiveness and safety (21 CFR 312.22 ).
An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
An IND must be authorized prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application.
Guidance on INDs is provided on the FDA web page .
IND Regulations are found in Title 21 of the Code of Federal Regulations (CFR), Part 312 (21 CFR 312 ).
Additional regulations that apply to INDs are found in 21 CFR as follows:
| 21 CFR Part 50 | Protection of Human Subjects |
| 21 CFR Part 54 | Financial Disclosure by Clinical Investigators |
| 21 CFR Part 56 | Institutional Review Boards |
| 21 CFR Part 58 | Good Laboratory Practice for Nonclinical Laboratory (Animal) Studies |
| 21 CFR Part 201 | Drug Labeling |
| 21 CFR Part 312 | Investigational New Drug Application |
| 21 CFR Part 314 | ANDA and NDA Applications for FDA Approval to Market a New Drug (New Drug Approval) |
| 21 CFR Part 316 | Orphan Drugs |
View the ReGARDD decision tree to determine if an IND is needed.
There are a few exceptions when an IND may not be needed for a clinical study.
To determine if an IND is required for a clinical study, it is critical that the FDA Guidance document Guidance for Clinical Investigators, Sponsors, and IRBs Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND, September 2013" is reviewed carefully.
INDs fall into two categories:
Commercial, submitted mainly by companies seeking marketing approval for a new drug.
Research (non-commercial).
The majority of INDs are filed for non-commercial research and are of three main types - (1) Investigator IND, (2) Emergency Use IND, and (3) Treatment (Compassionate Use) IND.