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:
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 |