Investigational Exemption for a New Drug

Table 1 Components of a Notice of Claimed Investigational Exemption for a New Drug (IND)... 

In the United States, the federal FD C Act and its amendments require that a manufacturer demonstrate the safety and efficacy of a new drug prior to introducing it into interstate commerce. The requirements are clearly spelled out in the Notice of Claimed Investigational Exemption for a New Drug (IND) and the NDA. 

The EPA defers to the FDA in this determination. pp follows the FDA s examples of when the FDA begins regulating a product this occurs when an application for exemption for an investigational use of a new drug, animal drug, or device is submitted. ... 

As stated in 321.21, A sponsor shall submit an IND if the sponsor intends to conduct a clinical investigation with a new drug. .. [and] shall not begin a clinical investigation until. .. an IND. .. is in effect. (Similar procedures are in place in other major countries. In the United Kingdom, for example, a clinical trials certificate (CTC) must be filed or a clinical trial exemption (CTX) obtained before clinical trials may proceed.) Clinical trials are divided into three phases, as described in 21 CFR 312.21. Phase I trials are initial introductions into healthy volunteers primarily for the purposes of establishing... 

Requests for permission to conduct clinical trials with pharmaceuticals in the US are termed Investigational New Drug Applications (INDs). The applications are actually a request for an exemption to supply a drug without a marketing authorisation. A cover sheet (Form 1571) must accompany the application. This cover sheet should also be used with each subsequent communication with the FDA, with each form consecutively numbered, starting at 000 for the initial submission. A copy of the form is shovm in Figure 5.6. 

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