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Author: Peter Feldschreiber Publisher: ISBN: 9780192847546 Category : Languages : en Pages : 512
Book Description
A practical guide for legal, medical, and pharmaceutical professionals, offering an authoritative and comprehensive source of expertise on the legislation and case law governing regulation of medicines and medical devices, and their liability under consumer protection law in the UK and EU.
Author: Peter Feldschreiber Publisher: ISBN: 9780192847546 Category : Languages : en Pages : 512
Book Description
A practical guide for legal, medical, and pharmaceutical professionals, offering an authoritative and comprehensive source of expertise on the legislation and case law governing regulation of medicines and medical devices, and their liability under consumer protection law in the UK and EU.
Author: James Beck Publisher: Law Journal Press ISBN: 9781588521217 Category : Actions and defenses Languages : en Pages : 982
Book Description
This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309212456 Category : Medical Languages : en Pages : 318
Book Description
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309162904 Category : Medical Languages : en Pages : 141
Book Description
The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
Author: John J. Tobin Publisher: John Wiley & Sons ISBN: 3527644717 Category : Science Languages : en Pages : 304
Book Description
Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.
Author: Peter Feldschreiber
Author: Peter Feldschreiber
Author: I. Glenn Cohen
Author: Suzan Onel
Author: John O'Grady
Author: James Beck
Author: Jonathan S. Kahan
Author: Institute of Medicine
Author: Institute of Medicine
Author: John J. Tobin
Author: Annetine C. Gelijns