IND applications

The content of the application is quite similar to EU requirements, although the structure and terminology is slightly different. The main headings are shown in Table 5.5. However, the FDA will now also accept IND application dossiers structured according to the CTD format (see Chapter 6 for the CTD format). 

Once the initial IND application has been assigned a reference number, the sponsor can keep submitting information to the FDA file to enable the clinical development to move through the various trial phases. 

CFR - Part 312.33 discusses what is required for an Investigational New Drug (IND) application. Part 312.33 discusses the requirements for the annual reporting for the IND. This reporting requires you to create adverse event, death, and subject dropout summaries annually for any drug under an IND application. 

After completing preclinical testing, a company files an Investigational New Drug (IND) application with the regulators (the FDA in the U.S.), so that clinical studies in man can begin. The IND shows results of all experiments to this point, a detailed proposal for the clinical study, the expected mode of action for the drug, and any side effects observed. All clinical trials will also be reviewed and approved by the Institutional Review Board (IRB) at the clinic where the trials will be run. 

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...

CFR 312.32 Safety reports for investigational products subject to an IND application (published 1987). 

An Investigational New Drug (IND) application to the FDA seeks permission for a human chnical trial to be conducted. An IND apphcation is detailed under 21 CFR Part 312. The process for an IND is summarized in Fig. 8.2. 

Reduces the amount of information required to be submitted to FDA as part of an IND application. 

The clinical drug development process required by the US FDA, arguably the most stringent in the world, starts with the investigational new drug (IND) application prior to human testing. It reveals information about all known compounds to be used and includes the description of the clinical research plan for the product as well as the protocol for phase I studies. Preclinical study results also need to be revealed. 

Once the IND application is accepted, three phases of human trials must be conducted. Phase I studies are typically performed on a small number of normal subjects, usually not more than 30 volunteers, generally by clinical pharmacologists. The purpose of the phase I smdy is to determine the metabolism of the drug in humans and a safe dosage range, and to search for any extremely common toxic effects that were not detected in the prior animal studies. 

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