What is the documentation required by the FDA to be filled out for a new drug prior to its marketing?

The New Drug Application (NDA) is the critical documentation required by the FDA to be submitted before a new drug can be marketed. This comprehensive application includes detailed information about the drug's pharmacology, therapeutic effects, potential side effects, manufacturing processes, labeling, and proposed usage indications. Essentially, it serves as a formal proposal submitted by a pharmaceutical company to market a new drug in the United States after completing all necessary preclinical and clinical trials.

The NDA is designed to provide the FDA with all the necessary data to determine whether the new drug is safe and effective for its intended use, therefore ensuring that it meets the regulatory standards for approval. This process is vital to maintain public health and safety by scrutinizing the efficacy and safety profiles of medications before they become available to consumers.