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Product Description
The Third Edition of A Practical Guide to Food and Drug Law and Regulation has been significantly updated and revised from the Second Edition, including incorporation of the Food and Drug Administration Amendments Act and other new laws passed since 2002. It also includes three new chapters: Combination Products, Pharmacovigilance and Regulation of Medical Research. A Practical Guide remains the single best resource for anyone needing a basic, uncomplicated understanding of the myriad requirements enforced by the Food and Drug Administration.
"'A Practical Guide' has served for many years as an outstanding primary resource for those who need a basic, plain language explanation of the laws and regulations affecting FDA-regulated products. The book should be required reading for anyone entering a company whose products are regulated by FDA, for law school students or for experienced lawyers, regulatory affairs practitioners, and consultants who want a clear explanation of the basis of FDA regulation." -- Alan Bennett, Managing Partner, Ropes and Gray
"'A Practical Guide' has served for many years as an outstanding primary resource for those who need a basic, plain language explanation of the laws and regulations affecting FDA-regulated products. The book should be required reading for anyone entering a company whose products are regulated by FDA, for law school students or for experienced lawyers, regulatory affairs practitioners, and consultants who want a clear explanation of the basis of FDA regulation." -- Alan Bennett, Managing Partner, Ropes and Gray