The FDCA Statutory Supplement, 2021 is an indispensable tool for FDA law practitioners. This publication provides cross-referencing of the numerous legislative amendments with the original statute, facilitating quick research and citation, and highlights recent changes through simple formatting. This edition is updated to incorporate the CARES Act and other statutory amendments since the 2018 edition. The appendix contains relevant portions of related statutes. This publication is available in both print and E-book versions.

The FDCA Statutory Supplement, 2018 is the indispensable tool for FDA law practitioners. Cross-referencing of the numerous legislative amendments with the original statute facilitates quick research and citation, and recent changes are highlighted with simple formatting. Access to an electronic version is included with each print copy.

"Pharmacy Practice and the Law helps Pharmacy students understand and critically analyze the law that governs both the profession and the products they distribute. Abood/Burns includes the most up-to-date federal, legal, regulatory, and policy developments, as well as new developments to various medical/pharmaceutical programs"--

This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.

The Preparation of a Product Liability Case offers substantive analysis and practical, expert guidance on analyzing theories of liability, conducting pre-trial discovery and discovery of particular information, introducing crucial evidence, and planning litigation strategies. You'll find all the hands-on guidance you need to tackle such essential aspects of the product liability litigation process as: Strict liability, including the design defect, manufacturing defect, and marketing defect theories Failure to warn Breach of warranty Admissibility of remedial measures Defenses, including alteration of the product, compliance with government standards, and open and obvious defects Investigating and preparing a product liability action Helpful practice guides include numerous checklists and sample forms, as well as appendices of interrogatories, sample jury charges, and safety briefs in specific types of cases.

Most environmental statutes passed since 1970 have endorsed a pragmatic or 'precautionary' principle under which the existence of a significant risk is enough to trigger regulation. At the same time, targets of such regulation have often argued on grounds of inefficiency that the associated costs outweigh any potential benefits. In this work, Jason Johnston unpacks and critiques the legal, economic, and scientific basis for precautionary climate policies pursued in the United States and in doing so sheds light on why the global warming policy debate has become increasingly bitter and disconnected from both climate science and economics. Johnston analyzes the most influential international climate science assessment organizations, the US electric power industry, and land management and renewable energy policies. Bridging sound economics and climate science, this pathbreaking book shows how the United States can efficiently adapt to a changing climate while radically reducing greenhouse gas emissions.