Medical Biotechnology: Premarket and Postmarket Regulation
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Providing a current and concise introduction to U.S. Food and Drug Administration (FDA) and related federal regulation of medical devices, drugs, and biological products derived from biotechnology, this concise new guide assists attorneys who need to understand the often complicated infrastructure that governs their clients in the biotechnology industry. Based on the understanding that nearly every legal issue related to biotech clients is ultimately informed or influenced by this governing legal framework, Medical Biotechnology: Premarket and Postmarket Regulation helps lawyers in all areas, whether prosecuting biotechnology patents, negotiating IP licenses, or handling product liability issues, to name just a few. With significant experience counseling clients on a wide range of biotechnology issues, the book's authors have either worked at the FDA or have been nationally recognized for their expertise in biotechnology law, or both. Clearly written and thorough, the book's chapters also include valuable information for practitioners, including Practice Tips, acronym lists for each chapter, and extensive footnotes. Four chapters address key issues in this regulatory framework:
Chapter One explains federal regulation of preclinical research, including requirements for compliance and the penalties for noncompliance. It considers three categories of regulatory protection: protection of animals used in research; protection of the environment and public health; and protection of individuals conducting preclinical reseach.
Chapter Two provides an overview of FDA regulation of clinical trials of new biotechnology products for human use. Briefly describing the role of clinical research and the government entities that regulate it, it also discusses the roles and responsibilities of the parties involved in the research and the clinical process itself, and well as other relevant issues.
Chapter Three outlines the standard and expedited pathways to market for biotechnology products intended for human use. Chapter Four covers the notable federal laws regulations that affect production, distribution, and marketing strategies.