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This compilation includes the completely updated Federal Food,
Drug, and Cosmetic Act and other federal statutes relevant to food
and drug law. This edition is current through June 2019 and
incorporates, among other changes, the amendments made by the Right
to Try Act of 2017, the Animal Drug and Animal Generic Drug User
Fee Amendments of 2018, and the SUPPORT for Patients and
Communities Act.
Roughly 20-25 cents out of every dollar spent by American consumers
is for a product regulated by the U.S. Food and Drug
Administration. The agency has jurisdiction over food, drugs,
cosmetics, medical devices, biological products (including
vaccines), animal food and drugs, and tobacco products, as well as
electronic products that emit radiation and products that spread
communicable disease. FDA regulation thus touches most products
that fill the shelves of our supermarkets and drug stores and
virtually every product prescribed or used by the medical
profession. Indeed, few other agencies regulate products or
activities that play so intimate a role in our daily lives. Food
and Drug Law is the law governing the actions taken by FDA and its
sister agencies to oversee the safety of this vast universe of
products, to ensure that the labeling (and in some cases
advertising) of products is accurate and reliable, and to shepherd
safe and effective new medical products onto the market. The book
contains not only the most important court cases in the field, but
also materials that show how food and drug law is developed and
enforced outside of court, including: Federal Register notices,
warning letters, guidance documents, Congressional hearings and
investigations, scholarly research, media opinions, and many
others. Additionally, the authors offer significant original
content to guide the reader through the myriad complexities of the
field. Likewise, the Fifth Edition includes carefully curated notes
that illuminate the law in action. The Fifth Edition, like previous
editions, is an invaluable resource for practitioners. But the book
has been reorganized and edited from top to bottom to make it more
accessible than ever for students and professors. The Fifth Edition
completely updates the Fourth Edition of 2014 through February
2022. It addresses all statutory developments since 2014,
including, for example, the National Bioengineered Food Disclosure
Standard Act of 2016, the 21st Century Cures Act of 2016, the FDA
Reauthorization Action of 2017, the Right to Try Act of 2018, the
Pediatric Drugs and Devices Act of 2017, and the Coronavirus Aid,
Relief, and Economic Security Act of 2020. Every major development
of the past eight years is addressed, from the flood of new mobile
and digital devices to the vital work of the FDA during the
COVID-19 pandemic. The authors combine their knowledge of the rich
histories in each product area with a deep understanding of the law
and the agency to explain the current state of food and drug law
and signal where it might be headed.
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