ABSTRACT
Oxford Pharmaceutical Resources, Inc., Totowa, New Jersey, U.S.A.
I. INTRODUCTION
Submitting a New Drug Application (NDA) to the FDA requires a meticulous, well indexed, comprehensive, and readable prepared document. This chapter will describe the specifics needed to format, assemble, and submit an NDA that follows FDA regulations and ICH guidelines. It is the applicant’s responsibility to submit data that will satisfy the requirements of the Food, Drug, and Cosmetic Act and the Code of Federal Regulations (CFR) used by the FDA in the review and approval of safe and effective drug products in the United States. The ICH guidelines on safety and efficacy used for international submissions are very similar to FDA regulations for new product approval, having only slight differences according to each country’s requirements where the New Drug Application is submitted.
