New approach of investigational new drug application for sponser- investigator in pharmaceutical industry as per fda guidelines

Author: 
Shailendra Kumar Verma and Lavika Gandhi

Investigation of new drug is a submission to food and drug administration (FDA) requesting permission to initiate a clinical study of new drug products. Clinical investigators invoke a number of specific regulatory requirements if their study includes use of a pharmaceutical agent.

Studies using a drug that has not been approved by the Food and Drug Administration (FDA) or for indications not in the approved labeling may require filing an Investigational New Drug (IND) application with the FDA. If a study meets specific regulatory exemption criteria, then an

IND may not be needed. Individual investigators may meet the FDA definition of a sponsor investigator, in which case the application process is generally less complicated than for commercial sponsors, and this review addresses only this circumstance. The purpose of this article is to assist sponsor-investigators in preparing and submitting complete investigational new drug applications (INDs) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA). Sponsor-investigators seeking to do clinical research often do not have the regulatory knowledge or the resources to hire experts to help them with the IND submission process. Although not an exhaustive step-by-step instruction manual, this article highlights certain elements of this process to facilitate a sponsor-investigator’s successful submission of an IND. This article also discusses the IND review process and general responsibilities of sponsor-investigators related to clinical investigations.

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Engineering and Technology
Volume: 
5
Issue: 
4
Year of Publication: 
2017
How to Cite this article: 

Shailendra Kumar Verma and Lavika Gandhi, 2017, New approach of investigational new drug application for sponser- investigator in pharmaceutical industry as per fda guidelines, International Journal of Current Science and Technology, Vol.5, Issue, 4, pp. 402-408