New Drug Application (NDA)


A New Drug Application, frequently shortened to an NDA, is an application that companies researching and developing drugs need to fill out if they would like to formally ask for the FDA to approve a new pharmaceutical product for marketing and sale in the United States. The NDA should provide a wealth of information that shows that the proposed treatment is safe and effective for a specific condition. If treatments already exist for that specific condition, the application should demonstrate why the new treatment is more effective than existing treatments. The application also has to show that the manufacturing method and quality control procedures are adequate enough to prevent people from getting harmed by the drug and that the drug will be continually reviewed after it reaches the market.

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