Preparing NDA

A document which is submitted by sponsors requesting FDA approval to market a new drug for human use. contains that data to show that the drug is safe and efficacious for the intended population prepared to support the statements in the proposed package insert. Its purpose is to demonstrate that a drug is safe and effective for its intended use in the population studied. A drug developer must include everything about a drug—from preclinical data to Phase 3 trial data include reports on all studies, data, and analyses. - Proposed labeling Safety updates - Drug abuse information Patent information - Any data from studies that may have been conducted outside the United States - Institutional - review board compliance information - Directions for use