Drugs | New Drugs
New drugs are those that are marketed in the U.S. only after 1938, which accounts for virtually every drug on the market in the U.S. now. Most new drugs are subject to FDA’s new drug application (NDA) and FDA approval requirements. New drugs must have an FDA approved NDA or they must be subject to the appropriate OTC monograph to be marketed legally in interstate commerce.
FDAImports.com, LLC assists new drug application holders, manufacturers of new drugs, and new drug importers in complying with all relevant FDA regulations. If you have a drug product that may require an FDA approved NDA, contact FDAImports.com, LLC for a concise regulatory review of the product. We can help find The Way Through the FDA new drug approval process.