The Drug development process - Pharmaceutical Biotechnology: Concepts and Aapplications - page 95

Initial IND
application submitted
to FDA

FDA review
(30 days max)

Application
granted

Sponsor
provides
ammendments

Application withheld
(further information
required)

Figure 4.11 Outline of the IND application process

regarded as adequate (see below) by the FDA. An IND application can consist of up to 15
volumes of approximately 400 pages each. Once received by the FDA, it is studied to ensure
that:

• it contains suffi cient/complete information required;

• the information supplied supports the conclusion that clinical trial subjects would not be ex-

posed to an unreasonable risk of illness/injury (the primary FDA role being to protect public
health);

• the clinical investigator named is qualifi ed to conduct the clinical trials;

• the sponsor's product brochures are not misleading/incomplete.

Based on their fi ndings, the FDA may grant the application immediately or may require ad-
ditional information which the sponsor then submits as IND amendments (Figure 4.11). Once
clinical trials begin, the sponsor must provide the FDA with periodic updates, usually in the form
of annual reports. Unscheduled reports must also be submitted under a variety of circumstances,
including:

• if any amendments to the trial protocol are being considered;

• if any new scientifi c information regarding the product is obtained;

• if any unexpected safety observations are made.

During the clinical trial phase, the sponsor and FDA will meet on one or more occasions. A par-
ticularly important meeting is often the end of phase II meeting. This aims primarily to evaluate
and agree upon phase III plans and protocols. This is particularly important, as phase III trials are
the most costly and generate the greatest quantity of data, used later to support the drug approval
application.