U.S. Drug Supply, Investigational Drugs and E-Prescriptions 9781536174427

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Автор: Emil R. Berg
Название: U.S. Drug Supply, Investigational Drugs and E-Prescriptions
ISBN: 9781536174427
Издательство: Nova Science
Классификация:

Медицинское право и законодательство о медицинском обслуживании

ISBN-10: 1536174424
Обложка/Формат: Hardback
Страницы: 399
Вес: 0.87 кг.
Дата издания: 03.03.2020
Серия: Law & Criminology
Язык: English
Размер: 191 x 260 x 39
Читательская аудитория: Professional & vocational
Ключевые слова: Medical & healthcare law
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Поставляется из: Англии
Описание: Chapter 1 reports on the U.S. drug supply and the complex way it is interwoven with multiple stakeholders involved in each step of the process. When investigational drugs show promise for treating serious or life-threatening diseases, patients are often interested in obtaining access to them. Congress included a provision in the FDA Reauthorization Act of 2017 for GAO to review actions taken to facilitate access to these drugs. Chapter 2 describes (1) actions FDA and drug manufacturers have taken to broaden eligibility criteria for clinical trials, (2) actions FDA has taken to facilitate access to investigational drugs outside of clinical trials, and (3) information drug manufacturers have communicated to patients and physicians about access to investigational drugs outside of clinical trials. Chapter 3 reports on requiring e-prescriptions for coverage under part D of the Medicare program for prescription drugs that are controlled substances.

U.S. Drug Supply, Investigational Drugs and E-Prescriptions, Emil R. Berg