Six Enduring Principles for Preparing NDAS

Abstract

Six enduring principles for preparing New Drug Applications (NDAs) are advanced: Principle Number 1: An NDA is the document that supports the labeling of a drug, Principle Number 2: An NDA is the only “form” of a drug that most regulators will ever see. A firm should look at its NDA as an example of its finest work, Principle Number 3: NDAs are organized to facilitate review by the authorities, Principle Number 4: Group studies in a logical order, Principle Number 5: Standardization of format and consistency of content make for high quality applications, and Principle Number 6: Getting it submitted on time is important; but getting it right is more important if your goal is an approved application.