Formal proposal for FDA drug approval.

• A. Investigational New Drug (IND)
• B. Phase 1 clinical trials
• C. Post-Marketing Surveillance
• D. New Drug Application (NDA)

Answer: (D)

Submitting a New Drug Application is the formal request to the FDA to approve a drug for marketing. After preclinical work and completed clinical trials, the sponsor compiles safety and efficacy data, plus details on manufacturing and labeling, into the NDA. The FDA then reviews the package to determine if the drug’s benefits justify its risks and whether the labeling and manufacturing meet required standards. If the assessment is favorable, approval is granted and the drug can be marketed. The other stages—an Investigational New Drug filing to begin human testing, Phase 1 trials as initial human safety studies, and Post-Marketing Surveillance after approval to monitor safety in the broader population—are different steps in the development and regulation process.