The following resources should be helpful to applicants and manufacturers who are required to have an approved application before marketing or conducting a clinical trial. They provide information relevant to various application types. Much of the technical and scientific information will also be helpful for manufacturers of non-application drugs, such as over-the-counter (OTC) monograph products.
Types of Applications
Find detailed information about the following types of applications:
- Investigational New Drug Application regulations (IND) (21 CFR 312)
- Applications for FDA Approval to Market a New Drug (NDA) (21 CFR 314)
- Abbreviated New Drug Application (ANDA)
- Biologic License Application (BLA): General and Licensing (21 CFR 600 and 601)
Quality Related Guidances and Documents
Other Resources
The following resources provide additional details for specific types of applications:
Contact Information
CDER-OPQ-Inquiries@fda.hhs.gov
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Content current as of:
03/18/2025
