Full 10th Edition E-Book LINK

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LANDMARK LEGISLATION focuses on milestone food and drug law legislation. This volume contains significant United States Supreme Court decisions which impact on this highly regulated industry. Key government agencies are included. LINK

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ADMINISTRATIVE PRIMER focuses on the United States Food and Drug Administration’s administrative law process with practical illustrations from the Federal Register and Code of Federal Regulations. Freedom of Information Act are covered. LINK

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ENFORCEMENT focuses on the most up-to-date civil and criminal issues and legal cases. Seizure, debarment, civil penalties, criminal sanctions and other enforcement strategies are all discussed. LINK

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MEDICAL DEVICES focuses on the “how” of medical device regulation. Regulatory requirements are more complex due to the proliferation of medical devices. Post-market tracking and enforcement are covered. Radiation-emitting product regulation is included. LINK

Cost $48.95
HUMAN DRUG REGULATION focuses on the drug approval processes for generic and brand drugs, advertising, First Amendment, duty to warn, enforcement and Supreme Court decisions and their impact on pharmaceutical regulatory law. LINK

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BIOTECHNOLOGY and BIOLOGICS focuses on important issues concerning biologics. This volume includes the Center for Biologics Evaluation and Research (CBER) regulatory parameters. Biosimilars, vaccine compensation and enforcement issues are covered. LINK

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VETERINARY PRODUCTS focuses on the key issues concerning animal drugs, feeds, food safety and animal health products which are regulated through FDA’s Center of Veterinary Medicine (CVM). Antimicrobials, supplements and other issues are covered. LINK

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PERSONAL CARE COSMETIC PRODUCTS  focuses on key issues concerning the regulation of cosmetics under the Office of Cosmetics and Colors within FDA. Product classification, imports, terminology, safety and enforcement all remain critical issues. LINK

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FOOD LAW REGULATION focuses on food safety, recalls, health claims, imports, labeling pathogens, obesity and other important topics. Hailed as the most significant overhaul of food safety, the Food Safety Modernization Act milestone legislation and rules are discussed. LINK

Cost $44.95
DIETARY SUPPLEMENTS, HERBS AND BOTANICALS focuses on the impact of the Dietary Supplement Health and Education Act (DSHEA) legislation and details how these types of products are regulated.  Claims, enforcement and post-market surveillance are covered. LINK

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TOBACCO PRODUCTS REGULATION focuses on the why of the Family Smoking Prevention and Tobacco Control Act and how tobacco products regulated by the United Stated Food and Drug Administration. First Amendment issues and warnings are included. LINK

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Volume XII focuses on a myriad of issues pertinent to food and drug Law regulation. For example, what does the future hold in terms of food and drug regulation? How should FDA regulate tobacco products, food, human and veterinary drugs, biologics, medical devices, cosmetics and dietary supplements? The answer is multifaceted and complex. LINK