Monthly Catalog of United States Government Publications PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Monthly Catalog of United States Government Publications PDF full book. Access full book title Monthly Catalog of United States Government Publications by . Download full books in PDF and EPUB format.
Author:
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 1122
Get Book Here
Book Description
Author:
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 1122
Get Book Here
Book Description
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 200
Get Book Here
Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
Get Book Here
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:
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 236
Get Book Here
Book Description
Author: Center for Drug Evaluation and Research (U.S.)
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 44
Get Book Here
Book Description
Author: Binghe Wang
Publisher: John Wiley & Sons
ISBN: 0471794414
Category : Medical
Languages : en
Pages : 276
Get Book Here
Book Description
Drug-Drug Interactions in Pharmaceutical Development comprehensively reviews the relevant science, industrial practice, and regulatory agency positions on drug-drug interactions. It focuses on the evaluation of potential drug-drug interactions, allowing researchers to address risk factors before a drug is put to market. The book covers both clinical and nonclinical aspects for understanding drug-drug interactions as well as in vitro and in vivo studies for use in studying interactions at the drug discovery stage.
Author:
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages :
Get Book Here
Book Description
Author: United States. Congress. House. Committee on Government Reform. Subcommittee on Criminal Justice, Drug Policy, and Human Resources
Publisher:
ISBN:
Category : Abortifacients
Languages : en
Pages : 642
Get Book Here
Book Description
Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 104
Get Book Here
Book Description
Author: J. Rick Turner
Publisher: John Wiley & Sons
ISBN: 047007373X
Category : Mathematics
Languages : en
Pages : 298
Get Book Here
Book Description
This book acquaints students and practitioners in the related fields of pharmaceutical sciences, clinical trials, and evidence-based medicine with the necessary study design concepts and statistical practices to allow them to understand how drug developers plan and evaluate their drug development. Two goals of the book are to make the material accessible to readers with minimal background in research and to be straightforward enough for self-taught purposes. By bringing the topic from the early discovery phase to clinical trials and medical practice, the book provides an indispensable overview of an otherwise confusing and fragmented set of topics. The author’s experience as a respected scientist, teacher of statistics, and one who has worked in the clinical trials arena makes him well suited to write such a treatise.
