New Drug Application (NDA)
NDAA New Drug Application is the formal submission through which a company asks the FDA for approval to market a new prescription or over-the-counter drug.
It compiles everything learned about the drug, including clinical trial results, manufacturing details, proposed labeling and safety data, so that FDA reviewers can judge whether the benefits outweigh the risks for a specific use. Approval is tied to that use, that formulation and that manufacturer. Later uses require additional trials and supplemental applications.
The one purified CBD medicine on the market reached patients through this pathway, and its approval is the reason regulators treat CBD as a drug ingredient. Consumer hemp products have not gone through an NDA, so no claims about disease apply to them. Research on cannabinoids for other conditions continues, but until a drug application is approved for a use, that use remains investigational.