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Author : Baoyang Ding
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (125 download)
Download or read book Pharmaceutical Product Recall Management written by Baoyang Ding and published by . This book was released on 2021 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : United States. Food and Drug Administration
Publisher :
ISBN 13 :
Total Pages : 84 pages
Book Rating : 4.:/5 (319 download)
Download or read book FDA Compilation of Case Studies of Drug Recalls, March 1973 written by United States. Food and Drug Administration and published by . This book was released on 1973 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Baoyang Ding
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (139 download)
Download or read book Post-Recall Risk Management Strategies and Organisational Knowledge Retention written by Baoyang Ding and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical industry has encountered increasingly prevalent product recalls, whereas the internal mechanism that enables pharmaceutical firms to implement an effective recall management strategy has not been deeply investigated. This paper selects a 3x2 scenario-based vignette experiment with 230 quality managers in China, in which the external environment of recall crisis that is consisted of different recall locus (internal recall locus/supplier recall locus/industrial recall locus) and high/low market pressure has been manipulated to test the decisions of quality risk management and organizational knowledge retention. The results indicate that a closer locus of recall event and the lower level of market pressures result in more preventative post-recall quality risk management strategies, and these effects are positively moderated by the manager's risk propensity. In addition, this paper finds that preventative post-recall quality risk management strategies lead to more formal knowledge retention. This paper is among the first to apply enactment theory into supply chain risk management through an empirical approach and integrate institutional theory to construct external environment of the enactment process. The findings demonstrate that quality managers should think broadly about implementing more preventative risk management strategies and learning vicariously from others' failures to help prevent future quality issues.
Author : United States. Bureau of Drugs. Office of Compliance. Division of Industry Liaison
Publisher :
ISBN 13 :
Total Pages : 80 pages
Book Rating : 4.:/5 (3 download)
Download or read book FDA Compilation of Case Studies of Drug Recalls, March 1973 written by United States. Bureau of Drugs. Office of Compliance. Division of Industry Liaison and published by . This book was released on 1973 with total page 80 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Eric W. Orts
Publisher : Oxford University Press
ISBN 13 : 0198738536
Total Pages : 246 pages
Book Rating : 4.1/5 (987 download)
Download or read book The Moral Responsibility of Firms written by Eric W. Orts and published by Oxford University Press. This book was released on 2017 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines whether firms as organizations can be considered morally responsible for their actions. This question has profound practical implications as well as theoretical significance, not least when we are today so frequently confronted with misconduct in business.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309459575
Total Pages : 483 pages
Book Rating : 4.3/5 (94 download)
Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : Sowmya Dinamani Rao
Publisher :
ISBN 13 :
Total Pages : 94 pages
Book Rating : 4.:/5 (1 download)
Download or read book Risk Assessment and Analysis of Pharmaceutical Industry Due to Recalls written by Sowmya Dinamani Rao and published by . This book was released on 2017 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past five years, there have been 5900 recalls of drugs by the U.S. Food and Drug Administration (FDA) which created distraught consumers and shareholders of pharmaceutical companies. In addition, recalls cause disruption in the supply chain making the pharmaceutical companies vulnerable to various types of risks. These risks include the potential for losing customers and investors as well as the huge financial losses from fines, penalties, lawsuits, revenue loss, market share and increased operations costs. Purpose: The purpose of this research is to study the consequences of product recall on Pharmaceutical Company. Methodology: Event study methodology was used to study the financial impact of a product recall announcement. Multiple linear regression analysis was used to study the operational and reputation risk in terms of recall class (severity), recall reason, recall size, recall scope and size of the company. An interrupted time series design and segmented linear regression models were used to study regulation risk by examining the changes in Research & Development (R&D) expense and Operational expense, following the enforcement of Drug Quality and Security Act regulatory law passed on pharmaceutical companies following a Class I recall. Findings: The findings indicate that the recall class and recall scope have significant impact on financial, operational and reputation risks compared to the reason of the recall, recall size and the size of the company. The financial and reputational risks increased with the severity of the recall but not the operational risk. Operational risk is high for most reputable companies. The enforcement of regulatory law did not have much effect on large cap companies compared to small cap companies. Practical implication: The results from this study can be utilized to quickly determine which risks will require an immediate mitigation strategy based on the characteristics of the company and severity of the recall there by reducing significant damage to the company's reputation and financial cost.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 030922408X
Total Pages : 366 pages
Book Rating : 4.3/5 (92 download)
Download or read book Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-03 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.
Author :
Publisher :
ISBN 13 :
Total Pages : 556 pages
Book Rating : 4.:/5 (319 download)
Download or read book Regulatory procedures manual written by and published by . This book was released on 2004 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309163587
Total Pages : 589 pages
Book Rating : 4.3/5 (91 download)
Download or read book Enhancing Food Safety written by National Research Council and published by National Academies Press. This book was released on 2010-11-04 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.
Author : William A. Woods
Publisher : Lippincott Williams & Wilkins
ISBN 13 : 9780683306101
Total Pages : 548 pages
Book Rating : 4.3/5 (61 download)
Download or read book Emergency Medicine Recall written by William A. Woods and published by Lippincott Williams & Wilkins. This book was released on 2000 with total page 548 pages. Available in PDF, EPUB and Kindle. Book excerpt: Emergency Medicine Recall is an important addition to the successful RECALL series, which uses a double-column, rapid-fire, question and answer format to help medical students, residents, nurse practitioners, physician assistants and other healthcare professionals to recall important information presented on wards. This information also is critical for USMLE test preparation. The text contains many patient management questions that are written in the emergency room setting, thus preparing students for questions that address EM-specific issues.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309212456
Total Pages : 318 pages
Book Rating : 4.3/5 (92 download)
Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. 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.
Author : Jerry L. Mashaw
Publisher :
ISBN 13 : 9780674423466
Total Pages : 300 pages
Book Rating : 4.4/5 (234 download)
Download or read book The Struggle for Auto Safety written by Jerry L. Mashaw and published by . This book was released on 2013-10-01 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: Combining superb investigative reporting with incisive analysis, Jerry Mashaw and David Harfst provide a compelling account of the attempt to regulate auto safety in America. Their penetrating look inside the National Highway Traffic Safety Administration (NHTSA) spans two decades and reveals the complexities of regulating risk in a free society. Hoping to stem the tide of rising automobile deaths and injuries, Congress passed the National Traffic and Motor Vehicle Safety Act in 1966. From that point on, automakers would build cars under the watchful eyes of the federal regulators at NHTSA. Curiously, however, the agency abandoned its safety mission of setting, monitoring, and enforcing performance standards in favor of the largely symbolic act of recalling defective autos. Mashaw and Harfst argue that the regulatory shift from rules to recalls was neither a response to a new vision of the public interest nor a result of pressure by the auto industry or other interest groups. Instead, the culprit was the legal environment surrounding NHTSA and other regulatory agencies such as the EPA, OSHA, and the Consumer Product Safety Commission. The authors show how NHTSA's decisions as well as its organization, processes, and personnel were reoriented in order to comply with the demands of a legal culture that proved surprisingly resistant to regulatory pressures. This broad-gauged view of NHTSA has much to say about political idealism and personal ambition, scientific commitment and professional competition, long-range vision and political opportunism. A fascinating illustration of America's ambivalence over whether government is a source of--or solution to--social ills, The Struggle for Auto Safety offers important lessons about the design and management of effective health and safety regulatory agencies today.
Author : Blake Rayfield
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (13 download)
Download or read book Product Recalls, Lobbying, and Firm Value written by Blake Rayfield and published by . This book was released on 2019 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Purpose: The purpose of this paper is to use a unique, hand-collected data set of Food and Drug Administration (FDA)-approved products to understand the effect of lobbying on the product market. The authors gather total 86,462 FDA labels including drug patents, drugs, pre-market approvals and medical devices and test the relationship between lobbying and future firms' product submissions.Design/methodology/approach: Using a sample of 86,462 FDA labels including drug patents, drugs, pre-market approvals and medical devices, the authors test the effect of lobbying on a firm's future product submissions using survival analysis, logit, difference-in-differences and propensity score matching techniques.Findings: The authors find lobbying firms experience an increase in the number of medical products approved. However, increased number of FDA labeling comes at the cost of product failure. The authors document that lobbying increases product recalls when responsible firms are associated with higher market withdrawals.Originality/value: This study contributes to both the management literature on corporate lobbying and product recalls. Additionally, the study reveals the connection between pharmaceutical lobbying and firm value.
Author : Lorne H. Blackbourne
Publisher : Lippincott Williams & Wilkins
ISBN 13 : 1451176414
Total Pages : 822 pages
Book Rating : 4.4/5 (511 download)
Download or read book Surgical Recall written by Lorne H. Blackbourne and published by Lippincott Williams & Wilkins. This book was released on 2011-11-11 with total page 822 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now in its Sixth Edition, Surgical Recall allows for rapid-fire review of surgical clerkship material for third- or fourth-year medical students preparing for the USMLE and shelf exams. Written in a concise question-and-answer format—double-column, question on the left, answer on the right—Surgical Recall addresses both general surgery and surgical subspecialties. Students on rotation or being PIMPed can quickly refer to Surgical Recall for accurate and on-the-spot answers. The book includes survival tactics and tips for success on the boards and wards as well as key information for those new to the surgical suite.
Author : United States. Defense Logistics Agency
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (119 download)
Download or read book DoD Hazardous Food and Nonprescription Drug Recall System written by United States. Defense Logistics Agency and published by . This book was released on 1985 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Mr. Sachin Itkar
Publisher : Nirali Prakashan
ISBN 13 : 9788185790398
Total Pages : 244 pages
Book Rating : 4.7/5 (93 download)
Download or read book Pharmaceutical Management written by Mr. Sachin Itkar and published by Nirali Prakashan. This book was released on 2008-01-07 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt:
