New Drug Application An application to the FDA for approval to market a drug in the U.S. The FDA determines if a protein pharmaceutical is considered a drug or a biologic and whether an NDA or a PLA, respectively, should be filed to obtain marketing approval. ... (14 Nov 1997) ... Found on http://www.encyclo.co.uk/local/20973
New drug application. A package of information submitted by the sponsor of a treatment to the FDA, containing all of the information in support of the treatment's approval Found on http://www.virology.net/ATVGlossary.html