Investigational New Drug Application
In many ways, the investigational new drug (IND) application is the result of a successful preclinical development
program. The IND is also the vehicle through which a sponsor advances to the next stage of drug development known as
clinical trials (human trials).
During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is
reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial
development. When a product is identified as a viable candidate for further development, the sponsor then focuses on
collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks
when used in limited, early-stage clinical studies.
Generally, this includes data and information in three broad areas:
- Animal Pharmacology and Toxicology Studies
Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans.
- Manufacturing Information
Information pertaining to the composition, manufacture, stability, and controls used for manufacturing the drug
substance and the drug product. This information is assessed as to ensure the company can adequately produce and
supply consistent batches of the drug.
- Clinical Protocols and Investigator Information
Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to
unnecessary risks. Also, information on the qualifications of clinical investigators--professionals (generally physicians)
who oversee the administration of the experimental compound--to assess whether they are qualified to fulfill their
clinical trial duties.
The IND is not an application for marketing approval. Rather, it is a request for an exemption from the Federal
statute that prohibits an unapproved drug from being shipped in interstate commerce. Current Federal law requires that a
drug be the subject of an approved marketing application before it is transported or distributed across state lines.
Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must
seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this
exemption from the FDA; however, its main purpose is to detail the data that provide documentation that it is indeed
reasonable to proceed with certain human trials with the drug.
Types of INDs
"Commercial INDs" are applications that are submitted primarily by companies whose ultimate goal is to obtain marketing
approval for a new product. However, there is another class of filings broadly known as "noncommercial" INDs. The vast
majority of INDs are, in fact, filed for noncommercial research. These types of INDs include "Investigator INDs," "Emergency
Use INDs," and "Treatment INDs."
For a list of addresses to send applications to, go to the Address page.
Subject-Related CDER Guidances of Interest
Source: U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook.
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