Inside Fda When A Drug Is In Short Supply

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Inside Fda When A Drug Is In Short Supply

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Author :
language : en
Publisher: DIANE Publishing
Release Date :

Inside Fda When A Drug Is In Short Supply written by and has been published by DIANE Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on with categories.

Drug Shortages

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Author : U.s. Government Accountability Office
language : en
Publisher: Createspace Independent Publishing Platform
Release Date : 2017-08-10

Drug Shortages written by U.s. Government Accountability Office and has been published by Createspace Independent Publishing Platform this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-08-10 with categories.

" In recent years, nationwide shortages of prescription drugs have increased, preventing patients from accessing medications essential to their care. The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), established a Drug Shortage Program with a mission of helping to prevent, alleviate, and resolve shortages. FDA receives information about shortages from manufacturers, though this reporting is generally voluntary, as well as from the American Society of Health-System Pharmacists (ASHP). ASHP tracks nationwide shortages for its members through a partnership with the University of Utah Drug Information Service (UUDIS). GAO was asked to review trends in shortages and examine FDA's response. In this report, GAO (1) reviews trends in drug shortages, (2) describes FDA's response, and (3) evaluates FDA's ability to protect public health through its response to drug shortages. GAO analyzed UUDIS data, interviewed officials from FDA, health care professional associations, and industry, and also examined relevant statutes, regulations, information, and documents. "

National Drug Shortages

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Author : Reid T. Stephens
language : en
Publisher: Nova Science Pub Incorporated
Release Date : 2012-12-01

National Drug Shortages written by Reid T. Stephens and has been published by Nova Science Pub Incorporated this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-01 with Medical categories.

This book explores the trends and FDA response to national drug shortages. In recent years, hospitals and health care professionals have increasingly reported nationwide shortages of prescription drugs, including those that are life-saving and life-sustaining. Drug shortages directly threaten public health by preventing patients from accessing medications that are essential to their care. For example, recent shortages of oncology drugs have sparked concerns from health care professionals about how to care for cancer patients that need such medications in order to survive. During shortages, physicians may have to ration their supplies, delay treatments, or use alternative medications that may be less effective for the condition, carry unwanted side effects, or are most costly.

Fda S Contribution To The Drug Shortage Crisis

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Author : Darrell Issa
language : en
Publisher:
Release Date : 2013-02-24

Fda S Contribution To The Drug Shortage Crisis written by Darrell Issa and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-02-24 with Medical categories.

American patients and doctors confront an unprecedented shortage of critical drugs. The widespread shortages are causing inferior treatment regimens, interruptions in care, higher health care costs, and even premature death. The drugs in shortage are mostly generic injectable medications, many of which have been on the market for decades. Although the shortages have been attributed to a myriad of factors from a lack of raw materials to increased demand, information obtained by a Congressional Comm. shows that the crisis was largely sparked by actions of the Food and Drug Admin. (FDA). The Comm. learned that FDA regulatory activity has effectively shut down 30% of the total manufacturing capacity at four of America's largest producers of generic injectable medications. The drug shortage crisis began in 2010 shortly after Margaret Hamburg became FDA Commissioner. Since then, the FDA has failed to ensure that enforcement and compliance activities are conducted in a manner that does not create unnecessary shortages of critical drugs. Contents of this report: Extent of the Drug Shortage Crisis; Economics of Shortages; Growing Market Concentration Laid the Groundwork for the Drug Shortage; FDA's Role in Causing the Drug Shortages; Conclusion; Recommendations. Figures. This is a print on demand report.

Pain Management And The Opioid Epidemic

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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2017-09-28

Pain Management And The Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-28 with Medical categories.

Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

Bottle Of Lies

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Author : Katherine Eban
language : en
Publisher: HarperCollins
Release Date : 2020-06-23

Bottle Of Lies written by Katherine Eban and has been published by HarperCollins this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-06-23 with Medical categories.

A NEW YORK TIMES BESTSELLER New York Times 100 Notable Books of 2019 New York Public Library Best Books of 2019 Kirkus Reviews Best Health and Science Books of 2019 Science Friday Best Books of 2019 New postscript by the author From an award-winning journalist, an explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale—The Jungle for pharmaceuticals Many have hailed the widespread use of generic drugs as one of the most important public-health developments of the twenty-first century. Today, almost 90 percent of our pharmaceutical market is comprised of generics, the majority of which are manufactured overseas. We have been reassured by our doctors, our pharmacists and our regulators that generic drugs are identical to their brand-name counterparts, just less expensive. But is this really true? Katherine Eban’s Bottle of Lies exposes the deceit behind generic-drug manufacturing—and the attendant risks for global health. Drawing on exclusive accounts from whistleblowers and regulators, as well as thousands of pages of confidential FDA documents, Eban reveals an industry where fraud is rampant, companies routinely falsify data, and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit, confident in their ability to fool inspectors. Meanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects. The story of generic drugs is truly global. It connects middle America to China, India, sub-Saharan Africa and Brazil, and represents the ultimate litmus test of globalization: what are the risks of moving drug manufacturing offshore, and are they worth the savings? A decade-long investigation with international sweep, high-stakes brinkmanship and big money at its core, Bottle of Lies reveals how the world’s greatest public-health innovation has become one of its most astonishing swindles.

Fda In The Twenty First Century

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Author : Holly Fernandez Lynch
language : en
Publisher: Columbia University Press
Release Date : 2015-09-08

Fda In The Twenty First Century written by Holly Fernandez Lynch and has been published by Columbia University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-09-08 with Business & Economics categories.

In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.

Fda Consumer

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Author :
language : en
Publisher:
Release Date : 2000

Fda Consumer written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000 with Consumer protection categories.

Managing Supply Chain Risk

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Author : ManMohan S. Sodhi
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-02-25

Managing Supply Chain Risk written by ManMohan S. Sodhi and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-02-25 with Business & Economics categories.

“Supply Chain Risk Management is an issue that many companies face and yet few companies know how to deal with it in a systematic and pragmatic manner. While avoiding and reducing supply chain risks are certainly preferable, developing ways to restore and stabilize supply chain operations rapidly after a major disruption is critical for managing global supply chains. Sodhi and Tang present important concepts, frameworks, strategies, and analyses that are essential for managing supply chain risks. Not only does this book suggest some practical ways to work with different partners to manage the risks that are present in a global supply chain, it creates a framework that would enable practitioners to engage researchers to work on this important area.” —Thomas A. Debrowski, Executive Vice President, Worldwide Operations, Mattel, Inc. “When a firm outsources its operations to external suppliers, the firm is vulnerable to major and rare disruptions that can occur at any link in the global supply chain. Because these disruptions rarely occur, few firms take commensurable actions to identify, assess, mitigate and respond to various types of supply chain risks. By introducing frameworks and concepts along with several case studies and a review of academic literature, Sodhi and Tang treat this important subject with practical relevance and academic rigor. This book will bring practitioners and researchers to develop effective and efficient ways to manage supply chain risks.” —Marshall L. Fisher, UPS Professor, Professor of Operations and Information Management and Co-Director of Fishman-Davidson Center for Service and Operations Management, The Wharton School, University of Pennsylvania “This book ties observations in practice to methodologies and research. The rich case examples motivated the approaches and methodologies used to mitigate risks, and in the course of doing so, Sodhi and Tang provided insights on existing and new research opportunities. As a result, this book is highly relevant to both practitioners and academics. Also, the book is also written with management lessons on how risks can be mitigated, and how risks can be contained once disruptions have occurred. As such, it is also a book for management to gain insights and to develop management skills.” —Hau L. Lee, Thoma Professor of Operations, Information and Technology and Director of the Stanford Global Supply Chain Management Forum, Graduate School of Business, Stanford University “As companies have extended their supply chains globally and as the face increasing resource issues, they face a number of new risk challenges. While there are various case studies written about supply chain risks, this book gives a comprehensive treatment of the subject with clarity. The concepts and frameworks developed by Sodhi and Tang in this book would create awareness of this important and yet not well understood subject, and strategies described in this book would stimulate practitioners to develop a holistic approach for identifying, assessing, mitigating, and responding to different types of supply chain risks.” —Nick Wildgoose, Global Supply Chain Proposition Manager, Zurich Insurance​

Medical Countermeasures Dispensing

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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2010-12-16

Medical Countermeasures Dispensing written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-12-16 with Medical categories.

During public health emergencies such as terrorist attacks or influenza outbreaks, the public health system's ability to save lives could depend on dispensing medical countermeasures such as antibiotics, antiviral medications, and vaccines to a large number of people in a short amount of time. The IOM's Forum on Medical and Public Health Preparedness for Catastrophic Events held a workshop on November 18, 2009, to provide an overview of current threats, recent progress made in the public health system for distributing and dispensing countermeasures, and remaining vulnerabilities.