The Challenges of Regulating Drugs and New Technologies
Author: Holly Fernandez Lynch,I. Glenn Cohen
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.
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.
Although many were skeptical of the green chemistry movement atfirst, it has become a multimillion-dollar business. In preventingthe creation of hazardous wastes, laboratories and corporations cansave millions in clean up efforts and related health costs. Thisbook supplies students with concepts commonly taught inundergraduate general chemistry and general engineering courses,but with a green perspective. It is unique in presenting anintegrated discussion of green chemistry and engineering from firstprinciples – not as an afterthought. Real-world examples showcreative problem solving based on the latest issues.
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.
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.
United States. Congress. House. Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Ethical and Social Issues Arising Out of Advances in the Biomedical Sciences
Author: Dana Cook Grossman,Heinz Valtin
Publisher: New York Academy of Sciences
This volume presents addresses given to celebrate the bioentennial of the Dartmouta Medical School. Participants included James O. Freedman, Joseph L. Goldstein, Nancy Wexler, David Botstein, Francis S. Collins, Richard Axel, Gerald M. Edelman, Pasko Rakic, Marcus E. Raichle, Steven Pinker, Al Gore, Susan G. Dentzer, C. Everett Koop, Philip Kitcher, Daniel J Callahan, Lonnie R. Bristow, Ruth Purtilo, William L. Roper, Robert G. Evans, Nils M. Daulaire, Michael S. Teitelbaum, Thomas Horner-Dixon, Hania Zlotnick, S. Marsh Tenney, Sir David Weatherall, and Michael S. Brown, who discussed such intriguing issues as the Human Genome Project, the origin and substrate of thinking, the rationing of health care, world population pressures, and the prospects for biomedical research and education.
hearing before the Committee on Labor and Human Resources, United States Senate, One Hundredth Congress, first session, on examining the health and safety concerns of Nutrasweet (Aspartame), November 3, 1987
hearing before the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Ninth Congress, second session, on Andrew von Eschenbach, of Texas, to be Commissioner of Food and Drugs, Department of Health and Human Services; Paul DeCamp, of Virginia, to be Administrator of the Wage and Hour Division, Department of Labor, August 1, 2006
Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
"The third edition of this classic and indispensable work, first published in 1940 and last revised in 1976, has been updated completely for a new generation of students and scholars. Recognizing that the ways in which history is understood and interprete