Glossary
New drug application (NDA)
What is a New Drug Application?
New Drug Application (NDA) is the process through which drug manufacturers formally request approval from FDA to sell and market new pharmaceutical products in the United States. NDA provides FDA with a comprehensive understanding of the drug. To approve, FDA must determine that the drug is safe and effective for its intended use, that the benefits outweigh the risks, and the manufacturing process and control are adequate.
What information is required in an NDA?
New Drug Application (NDA) must provide detailed information, including:
- Results from animal studies and human clinical trials
- Drug composition and manufacturing processes
- Proposed labelling and packaging information
- Data supporting the drug’s pharmacokinetics and pharmacodynamics
How does the FDA evaluate an NDA?
The FDA reviews the New Drug Application (NDA) to determine:
- The safety and effectiveness of the drug
- The appropriateness of the proposed labelling
- Adequacy of manufacturing methods and controls to ensure drug quality
What happens if changes are needed after approval of NDA?
If changes to an approved New Drug Application (NDA) are necessary, the FDA provides guidance on how to submit these changes. Applicants must adhere to specific regulations regarding amendments and supplements to ensure compliance with FDA standards.
How does patent information relate to NDAs?
New Drug Application (NDA) holders are required to submit patent information at the time of application. This includes details about any patents covering the drug or its uses. The FDA does not notify NDA holders about exclusivity periods; this information is published in the Orange Book.
