A Practical Guide to Food and Drug Law and RegulationKenneth R. Piņa, Wayne L. Pines |
Contents
Introduction | 1 |
The Food and Drug Administration How it is Organized | 63 |
Chapter 5 | 89 |
Copyright | |
8 other sections not shown
Common terms and phrases
activities administrative adulterated advertising agency agency's Amendments ANDA approved drug authority bioequivalence biologics calories Center changes cholesterol choline clinical color additives compliance Congress consumers contains cosmetic court criminal crisis Delaney Clause dietary fiber dietary supplement disease documents drug applications DSHEA enforcement action ensure established FDA inspections FDA regulations FDA's FDAMA FDCA federal fiber food additive food and drug GRAS health claims individual industry infant formula ingredient injunction intended investigation issues 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 reference amount regulatory response risk safety and effectiveness saturated fat scientific seizure significant specific sponsor standards statement statutory studies submitted substance substantial tion ucts USDA violations Vitamin warning letter