FDA in the Twenty-First Century

The Challenges of Regulating Drugs and New Technologies

Author: Holly Fernandez Lynch,I. Glenn Cohen

Publisher: Columbia University Press

ISBN: 0231540078

Category: Business & Economics

Page: 528

View: 4832

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.

Law, Religion, and Health in the United States

Author: Holly Fernandez Lynch,I. Glenn Cohen,Elizabeth Sepper

Publisher: Cambridge University Press

ISBN: 1107164885

Category: Law

Page: 470

View: 9080

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.

Postwar America

An Encyclopedia of Social, Political, Cultural, and Economic History

Author: James Ciment

Publisher: Routledge

ISBN: 1317462351

Category: Business & Economics

Page: 2008

View: 707

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

Author: Ramesh C. Chandan,Arun Kilara,Nagendra P. Shah

Publisher: John Wiley & Sons

ISBN: 1118810317

Category: Science

Page: 696

View: 3145

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.

Handbook of Pharmaceutical Granulation Technology, Third Edition

Author: Dilip M. Parikh

Publisher: CRC Press

ISBN: 1616310030

Category: Medical

Page: 676

View: 1366

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.

Applications of Toxicogenomics in Safety Evaluation and Risk Assessment

Author: Darrell R. Boverhof,B. Bhaskar Gollapudi

Publisher: John Wiley & Sons

ISBN: 9781118008980

Category: Science

Page: 392

View: 2404

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.

Agriculture, Rural Development, and Related Agencies Appropriations for Fiscal Year 2006

Hearings Before a Subcommittee of the Committee on Appropriations, United States Senate, One Hundred Ninth Congress, First Session, on H.R. 2744, an Act Making Appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Programs for the Fiscal Year Ending September 30, 2006, and for Other Purposes

Author: United States. Congress. Senate. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, and Related Agencies

Publisher: N.A

ISBN: N.A

Category: Technology & Engineering

Page: 545

View: 3344

Nomination

hearing before the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Seventh Congress, second session on Mark McClellan, of the District of Columbia, to be Commissioner of Food and Drugs, October 7, 2002

Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions

Publisher: Government Printing Office

ISBN: N.A

Category: Political Science

Page: 56

View: 7628

Great Issues for Medicine in the Twenty-First Century

Ethical and Social Issues Arising Out of Advances in the Biomedical Sciences

Author: Dana Cook Grossman,Heinz Valtin

Publisher: New York Academy of Sciences

ISBN: 9781573311434

Category: Medical

Page: 277

View: 5885

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.

Nomination of Lester M. Crawford

hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Ninth Congress, first session, on [sic] to be Commissioner, Food and Drug Administration, U.S. Department of Health and Human Services, March 17, 2005

Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions

Publisher: Not Avail

ISBN: N.A

Category: Political Science

Page: 151

View: 5846

21st Century Cures

The President's Council of Advisors on Science and Technology (PCAST) Report on Drug Innovation : Hearing Before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, Second Session, May 20, 2014

Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health

Publisher: N.A

ISBN: N.A

Category: Drug development

Page: 185

View: 5036

The Food and Drug Import Safety Act

hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, on H.R. 3610, September 26, 2007

Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health

Publisher: Government Printing Office

ISBN: N.A

Category: Business & Economics

Page: 214

View: 1199

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2006

Hearings Before a Subcommittee of the Committee on Appropriations, House of Representatives, One Hundred Ninth Congress, First Session

Author: United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies

Publisher: Government Printing Office

ISBN: N.A

Category: Rural development

Page: N.A

View: 3065

CIS Annual

Author: N.A

Publisher: N.A

ISBN: N.A

Category: Government publications

Page: N.A

View: 1368