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Promotion of FDA-regulated Medical Products

2018 Advertising
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Release : 2018
Genre : Advertising
Kind : eBook
Book Rating : /5 ( reviews)

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Book Synopsis Promotion of FDA-regulated Medical Products by : Joanne S. Hawana

Download or read book Promotion of FDA-regulated Medical Products written by Joanne S. Hawana. This book was released on 2018. Available in PDF, EPUB and Kindle. Book excerpt: Promotion of FDA-Regulated Medical Products is the update of the 2013 publication, FDA requirements for prescription drug promotion, by John Driscoll.

Medical Devices and the Public's Health

2011-10-25 Medical
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Release : 2011-10-25
Genre : Medical
Kind : eBook
Book Rating : 456/5 ( reviews)

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Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine

Download or read book Medical Devices and the Public's Health written by Institute of Medicine. This book was released on 2011-10-25. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Dietary Supplements

1998 Advertising
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Release : 1998
Genre : Advertising
Kind : eBook
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Book Synopsis Dietary Supplements by : United States. Federal Trade Commission. Bureau of Consumer Protection

Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection. This book was released on 1998. Available in PDF, EPUB and Kindle. Book excerpt:

Complementary and Alternative Medicine in the United States

2005-04-13 Medical
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Release : 2005-04-13
Genre : Medical
Kind : eBook
Book Rating : 424/5 ( reviews)

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Book Synopsis Complementary and Alternative Medicine in the United States by : Institute of Medicine

Download or read book Complementary and Alternative Medicine in the United States written by Institute of Medicine. This book was released on 2005-04-13. Available in PDF, EPUB and Kindle. Book excerpt: Integration of complementary and alternative medicine therapies (CAM) with conventional medicine is occurring in hospitals and physicians offices, health maintenance organizations (HMOs) are covering CAM therapies, insurance coverage for CAM is increasing, and integrative medicine centers and clinics are being established, many with close ties to medical schools and teaching hospitals. In determining what care to provide, the goal should be comprehensive care that uses the best scientific evidence available regarding benefits and harm, encourages a focus on healing, recognizes the importance of compassion and caring, emphasizes the centrality of relationship-based care, encourages patients to share in decision making about therapeutic options, and promotes choices in care that can include complementary therapies where appropriate. Numerous approaches to delivering integrative medicine have evolved. Complementary and Alternative Medicine in the United States identifies an urgent need for health systems research that focuses on identifying the elements of these models, the outcomes of care delivered in these models, and whether these models are cost-effective when compared to conventional practice settings. It outlines areas of research in convention and CAM therapies, ways of integrating these therapies, development of curriculum that provides further education to health professionals, and an amendment of the Dietary Supplement Health and Education Act to improve quality, accurate labeling, research into use of supplements, incentives for privately funded research into their efficacy, and consumer protection against all potential hazards.

FDA Regulatory Affairs

2008-08-11 Medical
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Release : 2008-08-11
Genre : Medical
Kind : eBook
Book Rating : 974/5 ( reviews)

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Book Synopsis FDA Regulatory Affairs by : Douglas J. Pisano

Download or read book FDA Regulatory Affairs written by Douglas J. Pisano. This book was released on 2008-08-11. Available in PDF, EPUB and Kindle. Book excerpt: Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in

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