Which submission is used to obtain regulatory approval for a brand-new drug?

• A. Abbreviated New Drug Application
• B. Investigational New Drug
• C. Biologics License Application
• D. New Drug Application

Answer: (D)

Submitting a New Drug Application is the step used to obtain regulatory approval for a brand-new drug. This filing brings together all the evidence from preclinical studies and clinical trials (phases I–III), plus details on manufacturing, quality control, labeling, and proposed use. The FDA reviews this comprehensive package to decide whether the drug is safe and effective enough for its intended use and whether benefits justify risks before it can be marketed.

Understanding the others helps place this in context: an Investigational New Drug submission is what a sponsor files to begin human testing, not to win marketing approval. A Biologics License Application is the parallel pathway for biologic products (like certain proteins or vaccines), separate from conventional small-molecule drugs. An Abbreviated New Drug Application is for generic versions of an already approved product, demonstrating bioequivalence rather than proving safety and efficacy anew.