New Drug Applications INDs

INDs are among the most complex and critical of regulatory submissions. Most INDs run thousands of pages (often as many as 15 volumes) and may take months of assembly effort. 

The IND is the application to allow testing of a new drug (or biological) on human subjects in formal clinical trials. Since the FDA s primary function is to assure the public s health and safety, approval of the IND is contingent on compelling evidence of the relative safety of the drug under consideration and on the safety of the controls built into the proposed clinical studies. 

Since the IND is often the first formal communication with the FDA, it often sets the tone for ongoing FDA relations. A reputation for care and diligence, built with a strong IND, can strengthen continuing interactions, while a poorly designed or incomplete IND can sour the same future relationships. 

Guidebook for Drug Regulatory Submissions, by Sandy Weinberg Copyright 2009 John Wiley Sons, Inc. 

The result of this different (informal) standard of review is driving initial research into the public not-for-profit sector, with commercial drug companies tending to become involved in later stages (phases 2 and 3) of development. The process effectively provides greater flexibility early in the development process while carefully controlling more extensive and intensive clinical trials. 

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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. 

Investigational New Drug Applications (INDs), NDAs, Premarket Approval Applications (PMAs), Premarket Notifications (5 lO(k)s), Investigational Device Exemptions (IDEs), Biological Master Files (BMFs) and DMFs that are referenced in the current application. 

Lumpkin, M. (1996). Guidance for Industry Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including well-characterized, therapeutic, and biotechnology-derived products, http //www.fda.gov/cder/guidance/phasel.pdf... 

Investigational New Drug Application (IND)—The pharmaceutical industry sometimes provides advice to the FDA prior to submission of an IND. Sponsors—companies, research institutions, and other organizations that... 

An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials. 

The FDA is responsible for the review and market approval of new drugs, biologies, and medical devices in the United States under the authority of the Federal Food Drug and Cosmetic Act (the Act) and Section 351 of the Public Health Service Act (the PHS Act). The FDA defines premarket review as the examination of data and information in an application as described in Sections 505, 510(k), 513(f), 515, or 520(g) or 520(1) of the Act or Section 351 of the PHS Act. This refers to the premarket review of data and information contained in any Investigational New Drug application (IND), Investigational Device... 

Checklist of Required Elements for an Investigational New Drug Application (IND 21 CFR 312.23)... 

Labeling of an investigational new drug Subpart B—Investigational New Drug application (IND)... 

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