Generic drugs have been around for many years. The Drug Price Competition and Patent Term Restoration Act 1984 makes the abbreviated new drug application process available to drugs approved after 1962. It does not lower any standards for generic drugs. FDA's comprehensive drug approval process evaluates information concerning (1) chemistry, manufacturing, and controls, (2) in vivo bioequivalence, (3) labeling, (4) in vitro dissolution data where applicable, and (5) inspection and auditing of all facilities. This stringent and comprehensive approval process ensures the quality of generic drug products marketed in the US and assures the health professionals and patients of the safety and efficacy of generic drug products.
