Which term describes the FDA submission to market a new medication?

Which term describes the FDA submission to market a new medication?

• A. Investigational New Drug (IND)
• B. Phase II Testing
• C. New Drug Application (NDA)
• D. Placebo

Answer: (C)

The New Drug Application is the FDA submission used to request approval to market a new medication. After completing preclinical work and clinical trials that establish safety and efficacy, the sponsor compiles comprehensive data on the drug’s clinical effects, pharmacology, manufacturing quality, and proposed labeling. Submitting this package to the FDA initiates the formal review process; if the agency approves the NDA, the drug can be marketed in the United States with the agreed-upon labeling and post-marketing requirements. By contrast, an Investigational New Drug submission starts human testing, Phase II is a mid-stage trial, and a placebo is an inert control used in trials.

The New Drug Application is the FDA submission used to request approval to market a new medication. After completing preclinical work and clinical trials that establish safety and efficacy, the sponsor compiles comprehensive data on the drug’s clinical effects, pharmacology, manufacturing quality, and proposed labeling. Submitting this package to the FDA initiates the formal review process; if the agency approves the NDA, the drug can be marketed in the United States with the agreed-upon labeling and post-marketing requirements. By contrast, an Investigational New Drug submission starts human testing, Phase II is a mid-stage trial, and a placebo is an inert control used in trials.