The investigational new drug application

An investigational new drug is a new chemical-based, biologic or biopharmaceutical substance for which the FDA has given approval to undergo clinical trials. An IND application should contain information detailing preclinical findings, method of product manufacture and proposed protocol for initial clinical trials (Table 4.9).

In some instances, the FDA and drug sponsor (company/institution submitting the IND) will agree to hold a pre-IND meeting. This aims to acquaint the FDA officials with the background to/content of the IND application, and to get a feel for whether the IND application will be

Table 4.9 The major itemized points that must be included/ addressed in an IND application to CDER or CBER

FDA Form 1571

Table of (IND) contents


Proposed trial detail and protocol (general investigational plan) Investigator's brochure

Chemistry (or biology, as appropriate) manufacturing, and control detail Pharmacology and toxicology data

Any previous human experience regarding the drug substance Any additional information

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 sufficient/complete information required;

• the information supplied supports the conclusion that clinical trial subjects would not be exposed to an unreasonable risk of illness/injury (the primary FDA role being to protect public health);

• the clinical investigator named is qualified to conduct the clinical trials;

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

Based on their findings, the FDA may grant the application immediately or may require additional 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 scientific 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 particularly 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.

Table 4.10 An overview of the contents of a typical new NDA

Section 1 Section 2 Section 3 Section 4 Section 5 Section 6 Section 7 Section 8 Section 9 Section 10 Section 11 Section 12


Overall summary

Chemistry, manufacturing and control section

Sampling, methods of validation, package and labelling

Non-clinical pharmacology and toxicology data

Human pharmacokinetics and bioavailability data

Microbiology data

Clinical data

Safety update reports

Statistical section

Case report tabulations

Case report forms

Patent information and certification

Additional pertinent information

Sections 13 and 14 Section 15

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