NDA Submission

NDA submission refers to the process where a pharmaceutical company provides a comprehensive application to regulatory authorities, like the FDA, seeking approval to market a new drug. This application includes detailed information about the drug’s safety, effectiveness, manufacturing, and labeling. The goal is for regulators to review the data thoroughly and determine whether the drug is safe for public use and meets quality standards. Once approved, the drug can be legally sold and prescribed. NDA submission is a critical step in bringing a new medication from development to the market.