New Drug Application (NDA)

Definition

A New Drug Application (NDA) is a regulatory submission to the U.S. Food and Drug Administration (FDA) for approval to market a new pharmaceutical for sale and use. It includes data on the drug's safety, efficacy, and manufacturing processes.

5 Must Know Facts For Your Next Test

1. The NDA process is crucial for ensuring that new drugs are safe and effective before they reach the market.
2. An NDA must include clinical trial data, which often involves microbial genetics studies in gene therapy contexts.
3. The FDA reviews NDAs to determine whether the benefits of a new drug outweigh its risks.
4. Gene therapy products submitted through NDAs may involve genetically modified microorganisms.
5. Approval of an NDA allows the sponsor to market the drug in interstate commerce.

Review Questions

• What types of data must be included in a New Drug Application?
• Why is the NDA process important in the context of gene therapy?
• How does microbial genetics play a role in NDAs for gene therapy products?

Related terms

Investigational New Drug (IND) application: Application submitted to FDA before starting clinical trials on humans.

Biologics License Application (BLA): Submission for approval of biologic products such as vaccines or gene therapies.

Good Manufacturing Practice (GMP): Regulations requiring manufacturers to ensure their products are consistently produced and controlled according to quality standards.