The Challenges of Regulating Drugs and New Technologies
Author: Holly Fernandez Lynch
Publisher: Columbia University Press
Category: Business & Economics
In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.
An Encyclopedia of Social, Political, Cultural, and Economic History
Author: James Ciment
Category: Business & Economics
From the outbreak of the Cold War to the rise of the United States as the last remaining superpower, the years following World War II were filled with momentous events and rapid change. Diplomatically, economically, politically, and culturally, the United States became a major influence around the globe. On the domestic front, this period witnessed some of the most turbulent and prosperous years in American history. "Postwar America: An Encyclopedia of Social, Political, Cultural, and Economic History" provides detailed coverage of all the remarkable developments within the United States during this period, as well as their dramatic impact on the rest of the world. A-Z entries address specific persons, groups, concepts, events, geographical locations, organizations, and cultural and technological phenomena. Sidebars highlight primary source materials, items of special interest, statistical data, and other information; and Cultural Landmark entries chronologically detail the music, literature, arts, and cultural history of the era. Bibliographies covering literature from the postwar era and about the era are also included, as are illustrations and specialized indexes.
Dairy Processing and Quality Assurance, Second Edition describes the processing and manufacturing stages of market milk and major dairy products, from the receipt of raw materials to the packaging of the products, including the quality assurance aspects. The book begins with an overview of the dairy industry, dairy production and consumption trends. Next are discussions related to chemical, physical and functional properties of milk; microbiological considerations involved in milk processing; regulatory compliance; transportation to processing plants; and the ingredients used in manufacture of dairy products. The main section of the book is dedicated to processing and production of fluid milk products; cultured milk including yogurt; butter and spreads; cheese; evaporated and condensed milk; dry milks; whey and whey products; ice cream and frozen desserts; chilled dairy desserts; nutrition and health; sensory evaluation; new product development strategies; packaging systems; non-thermal preservation technologies; safety and quality management systems; and dairy laboratory analytical techniques. This fully revised and updated edition highlights the developments which have taken place in the dairy industry since 2008. The book notably includes: New regulatory developments The latest market trends New processing developments, particularly with regard to yogurt and cheese products Functional aspects of probiotics, prebiotics and synbiotics A new chapter on the sensory evaluation of dairy products Intended for professionals in the dairy industry, Dairy Processing and Quality Assurance, Second Edition, will also appeal to researchers, educators and students of dairy science for its contemporary information and experience-based applications.
While the law can create conflict between religion and health, it can also facilitate religious accommodation and protection of conscience. Finding this balance is critical to addressing the most pressing questions at the intersection of law, religion, and health in the United States: should physicians be required to disclose their religious beliefs to patients? How should we think about institutional conscience in the health care setting? How should health care providers deal with families with religious objections to withdrawing treatment? In this timely book, experts from a variety of perspectives and disciplines offer insight on these and other pressing questions, describing what the public discourse gets right and wrong, how policymakers might respond, and what potential conflicts may arise in the future. It should be read by academics, policymakers, and anyone else - patient or physician, secular or devout - interested in how US law interacts with health care and religion.
The Third Edition presents all pharmaceutical industry personnel and those in academia with critical updates on the recent advances in granulation technology and changes in FDA regulatory guidelines. Addressing precisely how these recent innovations and revisions affect unit operation of particle generation and granulation, this text assists the reader in selecting the ideal technology for his/her company’s particular drug delivery system. This knowledge helps ensure that regulatory guidelines are followed and met in a cost-effective manner. Here are just a few of the new topics discussed in this revised and expanded handbook: spray drying nanotechnology biotechnologically derived drugs nutraceuticals controlled release drugs particle engineering supercritical fluids concepts of design space process optimization regulation harmonization by global health authorities process controlexpert systems Process Analytical Technology (PAT) regulatory issues in granulation In addition, all chapters in the Handbook of Pharmaceutical Granulation Technology explore the fundamentals of powder characterization, granulation, and state-of-the-art technologies, modeling, application of expert systems, and manufacturing optimization.
This book provides a timely overview of toxicogenomics, with special emphasis on the practical applications of this technology to the risk assessment process. Introductory sections are followed by a series of chapters highlighting practical and systematic applications of toxicogenomics in informing the risk assessment process – including the areas of mutagenicity, carcinogenicity, endocrine toxicity, organ-specific toxicity, population monitoring, and ecotoxicology. The book concludes with approaches for the integration of this technology in safety evaluation studies, and an outlook on how toxicogenomics and complementary technologies can reframe the current risk assessment paradigm.