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The Philosophy of Food and Drug
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activities administrative adulterated advertising agency agency's Amendments ANDA approved drug authority bioequivalence biologics changes choline clinical color additives compliance Congress consumers contains cosmetic court criminal crisis Delaney Clause dietary supplement disease documents drug applications DSHEA enforcement action ensure established export facilities FDA inspections FDA regulations FDA's FDAMA FDCA federal Federal Food food additive Food and Drug food safety govemment GRAS health claim individual industry infant formula injunction intended investigation involved issues lovastatin manufacturing practices medical devices medical products ment misbranded notification nutrient content claims off-label Office patent PMA supplement premarket approval prescription drugs procedures promotional protect public health regulatory response risk safety and effectiveness scientific seizure significant specific sponsor standards statement statutory studies submitted substance substantial sumers testing tion ucts USDA violations violative warning letter