•Regulatory requirement for drug development and approval in United States: review

ABSTRACT: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.INTRODUCTION:HISTORY:The research, development, and approval of a drug productis a continuous but lengthy process involving drugdiscovery, laboratory development, animal studies, clinicaltrials, and regulatory registration. This lengthy process isnecessary 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 preventmisbranding and adulteration of food and drugs yet it doesnot give the government any authority to inspect food anddrugs. The act was amended in 1912 (the SherleyAmendment) to prohibit labeling medicines with false andfraudulent claims. In 1931, the United States Food andDrug Administration (FDA) was formed. The provisions ofthe FDA are intended to ensure that: