New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biologics License Application (BLA), Investigational New Drug (IND) application
New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Biologics License Applications (BLAs), Investigational New Drug (IND) Applications
The following resources should be helpful to applicants and manufacturers who are required to have an approved application before marketing a product 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 and related information
Resources
Contact information
CDER-OPQ-Inquiries@fda.hhs.gov
