Administering an investigational drug to humans is subject to prior approval from regulatory authorities.
Investigational New Drug
An IND is a request for authorization to administer an investigational drug or biological product to humans with the objective to collect clinical data (e.g. safety, PK, efficacy, …).
IND in the U.S.
The FDA’s primary objectives in reviewing an IND are, in all phases of the investigation, to assure the safety and rights of subjects, and in phase 2 and 3 trials, to help assure the quality of the scientific evaluation of the drug’s effectiveness and safety.
For submission to the FDA, the IND application must contain manufacturing information on the product, data from animal pharmacology and toxicology studies with the product, clinical protocols and investigator information.
The central focus of the initial IND submission should be on the general investigational plan and the protocols for specific human studies.
The general principles and content/format of the IND application are dependent upon the applicable legal basis – legal basis is set out in the Code of Federal Regulations (CFR) Title 21 Part 312.