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    <description descriptionType="Abstract">&lt;div&gt;ABSTRACT:&lt;/div&gt;&lt;div&gt;In this paper a brief history and an overview of the regulatory process for drug approval in the United States through illustrations of Investigational New Drug (INDs) Applications and New Drug Applications (NDAs), abbreviated new drug applications (ANDAs) and supplemental new drug applications (SNDAs) are provided. For INDs, the regulatory requirements for a well-designed protocol, the role and responsibility of institutional review boards, and the applicability of treatment INDs are discussed. For NDAs, issues regarding the application of expanded access, the submission of abbreviated NDAs for a generic drug, the submission of supplemental NDAs for labeling changes, and the role and responsibility of advisory committees are addressed. Along with this a brief description of review steps taken by FDA is provided.&lt;/div&gt;&lt;div&gt;&lt;div&gt;INTRODUCTION:&lt;/div&gt;&lt;div&gt;HISTORY:&lt;/div&gt;&lt;div&gt;The research, development, and approval of a drug product&lt;/div&gt;&lt;div&gt;is a continuous but lengthy process involving drug&lt;/div&gt;&lt;div&gt;discovery, laboratory development, animal studies, clinical&lt;/div&gt;&lt;div&gt;trials, and regulatory registration. This lengthy process is&lt;/div&gt;&lt;div&gt;necessary to assure the effectiveness and safety of the drug product. In the United States, however, no regulations were put forth until the Pure Food and Drug Act was passed by Congress in 1906. The purpose of this act is to prevent&lt;/div&gt;&lt;div&gt;misbranding and adulteration of food and drugs yet it does&lt;/div&gt;&lt;div&gt;not give the government any authority to inspect food and&lt;/div&gt;&lt;div&gt;drugs. The act was amended in 1912 (the Sherley&lt;/div&gt;&lt;div&gt;Amendment) to prohibit labeling medicines with false and&lt;/div&gt;&lt;div&gt;fraudulent claims. In 1931, the United States Food and&lt;/div&gt;&lt;div&gt;Drug Administration (FDA) was formed. The provisions of&lt;/div&gt;&lt;div&gt;the FDA are intended to ensure that:&lt;/div&gt;&lt;/div&gt;</description>
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