generic drugs overview of anda review process ted sherwood office pharmaceutical science brand vs get better feel 1906 pure food and drug act establishes regulation 1938 cosmetic introduced safety standards 1962 kefauver harris amendments to the fda&c tightened requirement that must be effective 1984 hatch waxman created an abbreviated mechanism for approval copies all originally approved after by stating pre clinical testing did not have repeated generics what is main consumer concern regarding z do quality performance compare often triggered companies physicians legislative history a product comparable reference listed in dosage form strength route administration characteristics intended use prior this had independently stablish efficacy their patent & exclusivity protection ends or owner waives its rights fda requirements are met definition e when can
