Intro to Biotechnology
A new drug application (NDA) is a formal proposal submitted to regulatory authorities, such as the FDA in the United States, requesting approval for a new pharmaceutical drug to be marketed and sold. This application includes comprehensive data from clinical trials, information on drug formulation, manufacturing processes, labeling, and proposed usage. The NDA is a critical step in the drug discovery and development process, as it represents the culmination of extensive research aimed at ensuring the safety and efficacy of a new drug before it reaches consumers.
congrats on reading the definition of new drug application (NDA). now let's actually learn it.