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Author : Howard L. Dorfman
Publisher : Unknown
Page : 128 pages
File Size : 53,6 Mb
Release : 2021
Category : Drugs
ISBN : 1402438486
Author : Howard L. Dorfman
Publisher : Unknown
Page : 0 pages
File Size : 52,9 Mb
Release : 2018-07-03
Category : Drugs
ISBN : 1402431392
Pharmaceutical Compliance and Enforcement Answer Book provides a comprehensive overview of the regulatory issues faced by the different participants in the pharmaceutical industry.In an easy Q&A format, this resource discusses: The FDA's authority and potential actions to regulate prescription drugs and biologics both before and after approval by the agencyA facility's rights and compliance obligations during an inspection by the agencyHow to best evaluate a company's potential of being in violation and what to do to mitigate those risksWhat advertising and promotion of prescription drugs is permittedHow product liability issues overlap with FDA enforcement initiativesWhen criminal prosecution is used as part of the regulatory enforcement effortFilled with practical suggestions, Pharmaceutical Compliance and Enforcement Answer Book provides attorneys and compliance officers with a roadmap to effective compliance with FDA pharmaceutical regulations.
Author : Howard L. Dorfman
Publisher : Unknown
Page : 0 pages
File Size : 49,5 Mb
Release : 2015-05-07
Category : Drugs
ISBN : 1402423721
In an easy Q&A format, Pharmaceutical Compliance and Enforcement Answer Book 2015 describes: -The FDA's authority and potential actions to regulate prescription drugs and biologics -A facility's rights and compliance obligations -What advertising and promotion of prescription drugs is permitted -How product liability issues overlap with FDA enforcement -When criminal prosecution is used
Author : Christopher A. Myers,Kwamina Thomas Williford
Publisher : Unknown
Page : 2384 pages
File Size : 43,9 Mb
Release : 2018-11
Category : Auditing, Internal
ISBN : 1402431198
Representing the combined work of more than forty leading compliance attorneys, Corporate Compliance Answer Book helps you develop, implement, and enforce compliance programs that detect and prevent wrongdoing. You'll learn how to: Use risk assessment to pinpoint and reduce your company's areas of legal exposureApply gap analysis to detect and eliminate flaws in your compliance programConduct internal investigations that prevent legal problems from becoming major crisesDevelop records management programs that prepare you for the e-discovery involved in investigations and litigationSatisfy labor and employment mandates, environmental rules, lobbying and campaign finance laws, export control regulations, and FCPA anti-bribery standardsMake voluntary disclosures and cooperate with government agencies in ways that mitigate the legal, financial and reputational damages caused by violationsFeaturing dozens of real-world case studies, charts, tables, compliance checklists, and best practice tips, Corporate Compliance Answer Book pays for itself over and over again by helping you avoid major legal and financial burdens.
Author : Susan Onel,Karen M. Becker
Publisher : Unknown
Page : 1112 pages
File Size : 40,9 Mb
Release : 2016-11
Category : Medical instruments and apparatus
ISBN : 1402427743
This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.
Author : Andrew L. Bab,Kevin A. Rinker
Publisher : Unknown
Page : 0 pages
File Size : 52,7 Mb
Release : 2018-09-07
Category : Consolidation and merger of corporations
ISBN : 1402431287
M&A activity in the health care industry is at its highest level since the 1980s. Organized into four parts, this guide includes practical advice on how to address the various industry-specific issues arising in health care acquisitions.
Author : Patricia C. Kienle
Publisher : Unknown
Page : 0 pages
File Size : 49,6 Mb
Release : 2021-09-30
Category : Medical
ISBN : 158528629X
"Provides explanation of elements of USP Hazardous Drugs' Handling in Healthcare Settings and best practices to comply with the requirements and recommendations of the USP General Chapter"--Pref.
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse
Publisher : National Academies Press
Page : 483 pages
File Size : 45,9 Mb
Release : 2017-09-28
Category : Medical
ISBN : 9780309459570
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 : United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher : Unknown
Page : 32 pages
File Size : 42,6 Mb
Release : 1998
Category : Advertising
ISBN : UIUC:30112004816200
Author : National Research Council,Division on Engineering and Physical Sciences,Committee on Applied and Theoretical Statistics,Policy and Global Affairs,Committee on Science, Technology, and Law,Committee on Identifying the Needs of the Forensic Sciences Community
Publisher : National Academies Press
Page : 348 pages
File Size : 48,9 Mb
Release : 2009-07-29
Category : Law
ISBN : 9780309142397
Scores of talented and dedicated people serve the forensic science community, performing vitally important work. However, they are often constrained by lack of adequate resources, sound policies, and national support. It is clear that change and advancements, both systematic and scientific, are needed in a number of forensic science disciplines to ensure the reliability of work, establish enforceable standards, and promote best practices with consistent application. Strengthening Forensic Science in the United States: A Path Forward provides a detailed plan for addressing these needs and suggests the creation of a new government entity, the National Institute of Forensic Science, to establish and enforce standards within the forensic science community. The benefits of improving and regulating the forensic science disciplines are clear: assisting law enforcement officials, enhancing homeland security, and reducing the risk of wrongful conviction and exoneration. Strengthening Forensic Science in the United States gives a full account of what is needed to advance the forensic science disciplines, including upgrading of systems and organizational structures, better training, widespread adoption of uniform and enforceable best practices, and mandatory certification and accreditation programs. While this book provides an essential call-to-action for congress and policy makers, it also serves as a vital tool for law enforcement agencies, criminal prosecutors and attorneys, and forensic science educators.
Author : John Braithwaite
Publisher : Routledge
Page : 451 pages
File Size : 45,9 Mb
Release : 2013-10-08
Category : Social Science
ISBN : 9781135072902
First published in 1984, this book examines corporate crime in the pharmaceutical industry. Based on extensive research, including interviews with 131 senior executives of pharmaceutical companies in the United States, the United Kingdom, Australia, Mexico and Guatemala, the book is a major study of white-collar crime. Written in the 1980s, it covers topics such as international bribery and corruption, fraud in the testing of drugs and criminal negligence in the unsafe manufacturing of drugs. The author considers the implications of his findings for a range of strategies to control corporate crime, nationally and internationally.
Author : U. S. Customs and Border Protection
Publisher : Unknown
Page : 0 pages
File Size : 48,7 Mb
Release : 2015-10-12
Category : Education
ISBN : 1304100065
Explains process of importing goods into the U.S., including informed compliance, invoices, duty assessments, classification and value, marking requirements, etc.
Author : National Academies of Sciences, Engineering, and Medicine,Division of Behavioral and Social Sciences and Education,Board on Behavioral, Cognitive, and Sensory Sciences,Committee on the Science of Changing Behavioral Health Social Norms
Publisher : National Academies Press
Page : 171 pages
File Size : 53,5 Mb
Release : 2016-09-03
Category : Social Science
ISBN : 9780309439121
Estimates indicate that as many as 1 in 4 Americans will experience a mental health problem or will misuse alcohol or drugs in their lifetimes. These disorders are among the most highly stigmatized health conditions in the United States, and they remain barriers to full participation in society in areas as basic as education, housing, and employment. Improving the lives of people with mental health and substance abuse disorders has been a priority in the United States for more than 50 years. The Community Mental Health Act of 1963 is considered a major turning point in America's efforts to improve behavioral healthcare. It ushered in an era of optimism and hope and laid the groundwork for the consumer movement and new models of recovery. The consumer movement gave voice to people with mental and substance use disorders and brought their perspectives and experience into national discussions about mental health. However over the same 50-year period, positive change in American public attitudes and beliefs about mental and substance use disorders has lagged behind these advances. Stigma is a complex social phenomenon based on a relationship between an attribute and a stereotype that assigns undesirable labels, qualities, and behaviors to a person with that attribute. Labeled individuals are then socially devalued, which leads to inequality and discrimination. This report contributes to national efforts to understand and change attitudes, beliefs and behaviors that can lead to stigma and discrimination. Changing stigma in a lasting way will require coordinated efforts, which are based on the best possible evidence, supported at the national level with multiyear funding, and planned and implemented by an effective coalition of representative stakeholders. Ending Discrimination Against People with Mental and Substance Use Disorders: The Evidence for Stigma Change explores stigma and discrimination faced by individuals with mental or substance use disorders and recommends effective strategies for reducing stigma and encouraging people to seek treatment and other supportive services. It offers a set of conclusions and recommendations about successful stigma change strategies and the research needed to inform and evaluate these efforts in the United States.
Author : United States. Securities and Exchange Commission. Division of Enforcement
Publisher : Unknown
Page : 144 pages
File Size : 43,9 Mb
Release : 2008
Category : Corporation law
ISBN : STANFORD:36105063760578
Author : Benjamin van Rooij,D. Daniel Sokol
Publisher : Cambridge University Press
Page : 0 pages
File Size : 51,6 Mb
Release : 2022-08-04
Category : Law
ISBN : 1009280120
Compliance has become key to our contemporary markets, societies, and modes of governance across a variety of public and private domains. While this has stimulated a rich body of empirical and practical expertise on compliance, thus far, there has been no comprehensive understanding of what compliance is or how it influences various fields and sectors. The academic knowledge of compliance has remained siloed along different disciplinary domains, regulatory and legal spheres, and mechanisms and interventions. This handbook bridges these divides to provide the first one-stop overview of what compliance is, how we can best study it, and the core mechanisms that shape it. Written by leading experts, chapters offer perspectives from across law, regulatory studies, management science, criminology, economics, sociology, and psychology. This volume is the definitive and comprehensive account of compliance.