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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.
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.
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.
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.
Written primarily for third- and fourth-year medical students in clerkships, this new edition covers the core specialty areas within internal medicine, including cardiology, pulmonology, and oncology. Each chapter is written by faculty, students, and fellows and emphasizes diagnosis and treatment.
The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants.