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FDA Administrative Enforcement Manual

Autor Florence R. Parker
en Limba Engleză Hardback – 18 feb 2005
When a problem arises with a product regulated by FDA, the Agency can take a number of actions to protect the public health. Initially, the agency works with the manufacturer to correct the problem voluntarily. If that fails, administrative enforcement and legal remedies include asking the manufacturer to recall a product and having federal marshals seize products if a voluntary recall is not done. Drugs can be seized and medical devices can be detained and imports can be stopped at the port of entry until problems are corrected. If warranted, FDA can ask the courts to issue injunctions or prosecute those that deliberately violate the law. When warranted, criminal penalties-including prison sentences-are sought.
Ensuring that your company is in compliance at all times in all departments is a never-ending task. Failure to get it right, even once, can mean excessive fines, penalties, or possible debarment. The FDA Administrative Enforcement Manual explores the control of drug research in pharmaceutical, vaccine, biologic, biotechnology, medical device, and cosmeceutical industries. Introducing basic industry techniques, the author explores every day industry problems and presents suggested methods for applying the theory to resolve them.

The book covers the ten critical Administrative Enforcement areas, including recalls, application integrity, injunctions, seizures, and more. It supplements these topics with regulations, lawsuit case studies, enforcement information, and reference materials. Offering insight into the impact of FDA enforcement on the national and international pharmaceutical industry, practitioners and industry suppliers, the book provides an understanding of drug development and manufacturing regulations in the United States and shows you what it takes to keep your company in compliance. The only complete, single source available, the FDA Administrative Enforcement Manual draws on the author's experience in the trenches of the pharmaceutical industry with administrative enforcement activities.
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Specificații

ISBN-13: 9780849330674
ISBN-10: 084933067X
Pagini: 480
Ilustrații: 15 b/w images and 23 tables
Dimensiuni: 178 x 254 x 30 mm
Greutate: 1.01 kg
Ediția:New.
Editura: CRC Press
Colecția CRC Press
Locul publicării:Boca Raton, United States

Public țintă

Academic, Professional, and Professional Practice & Development

Cuprins

Department of Health and Human Services, U.S. Food and Drug Administration: Authority and Responsibility. Recalls: Corrections and Withdrawals. Civil Actions. Criminal Actions: Debarment, Disqualification, and Application Compliance and Integrity. Case Studies. Appendix 1.FD&C Act of 1938. Appendix 2.Drug Law History Synopsis. Appendix 3.Clinical Investigators. Appendix 4.FDA Administrative Procedures Act (FAPA). Glossary. Index.

Recenzii

"The only complete, single source available…the book provides an understanding of drug development and manufacturing regulations in the United States and how a company may comply with them."
--Anticancer Research

Descriere

A self-contained single source complete with pertinent references and practical outlines for policies and procedures, this book covers how to understand and comply with U.S. drug development and manufacturing regulations. It explores the control of drug research and the manufacturing industry, introduces basic industry experience and techniques, and presents tried and true methods for applying the theory to everyday problems. The author discusses the 10 critical administrative enforcement areas, including recall, application integrity, injunction, seizure, and more, then supplements the topics with regulations, lawsuit case studies, enforcement information, and reference material.