https://www.pli.edu/rss/answer-books en-us 2026 Practising Law Institute Thu, 30 Apr 2026 04:59:31 Z https://www.pli.edu/catalog/publications/answer-book/pharmaceutical-compliance-and-enforcement-answer-book/370672?tCode=WTC5_RSS01 Regulation, compliance, and enforcement (Communications and telecommunications) Enforcement (Life sciences) Practice skills (Life sciences) Pharmaceuticals Regulation, compliance, and enforcement (Life sciences) The Eleventh Edition has been extensively updated with significant developments across key areas of pharmaceutical regulation, including a new chapter on the FDA’s shift towards greater transparency and its impact on product liability exposure, updated insights on evolving evidence standards for drug approvals, and the latest best practices for navigating FDA inspections and remote regulatory assessments. It also reflects current rules and enforcement trends surrounding pharmaceutical advertising and promotional activity, provides and overview of the modern enforcement landscape for off-label promotion, and offers fresh analysis of major legal developments affecting False Claims Act exposure for manufacturers, including recent interpretations that may influence damages and qui tam actions. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 370672 370672 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/pharmaceutical-compliance-and-enforcement-answer-book/397730?tCode=WTC5_RSS01 Regulation, compliance, and enforcement (Communications and telecommunications) Enforcement (Life sciences) Practice skills (Life sciences) Pharmaceuticals Regulation, compliance, and enforcement (Life sciences) Q&A guide to the laws governing the pharmaceutical industry. Coverage of FDA regulation and enforcement, regulation of advertising and promotional activity, REMS, product liability, pharmaceutical price reporting, the FDCA, 21st Century Cures Act, and much more. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 397730 397730 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/pharmaceutical-compliance-and-enforcement-answer-book/447832?tCode=WTC5_RSS01 Regulation, compliance, and enforcement (Communications and telecommunications) Enforcement (Life sciences) Practice skills (Life sciences) Pharmaceuticals Regulation, compliance, and enforcement (Life sciences) The Eleventh Edition has been extensively updated with significant developments across key areas of pharmaceutical regulation, including a new chapter on the FDA’s shift towards greater transparency and its impact on product liability exposure, updated insights on evolving evidence standards for drug approvals, and the latest best practices for navigating FDA inspections and remote regulatory assessments. It also reflects current rules and enforcement trends surrounding pharmaceutical advertising and promotional activity, provides and overview of the modern enforcement landscape for off-label promotion, and offers fresh analysis of major legal developments affecting False Claims Act exposure for manufacturers, including recent interpretations that may influence damages and qui tam actions. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 447832 447832 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/privacy-law-answer-book/422965?tCode=WTC5_RSS01 Information privacy (Cybersecurity and data protection) Covers online privacy policies, the Children’s Online Privacy and Protection Act, mobile device privacy, financial privacy, medical privacy, workplace privacy, online behavioral advertising and tracking, and privacy enforcement and litigation. Includes a chapter on global privacy laws. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 422965 422965 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/privacy-law-answer-book/370687?tCode=WTC5_RSS01 Information privacy (Cybersecurity and data protection) Covers online privacy policies, the Children’s Online Privacy and Protection Act, mobile device privacy, financial privacy, medical privacy, workplace privacy, online behavioral advertising and tracking, and privacy enforcement and litigation. Includes a chapter on global privacy laws. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 370687 370687 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/privacy-law-answer-book/343871?tCode=WTC5_RSS01 Information privacy (Cybersecurity and data protection) Privacy Law Answer Book makes clear sense of the patchwork of federal, state, and international laws and regulations that govern how private-sector entities handle consumers’ electronic data and personal information in commercial settings. Among other topics, the book addresses online privacy policies, the Children’s Online Privacy and Protection Act (COPPA), mobile device privacy, financial privacy, medical privacy, workplace privacy, online behavioral advertising and tracking, the California Consumer Privacy Act (CCPA) and other recent state privacy laws, and privacy enforcement and litigation.  Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 343871 343871 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/attorney-client-privilege-answer-book/422947?tCode=WTC5_RSS01 Attorney-client privilege Q&A guidance on the issues attorneys frequently grapple with regarding the attorney-client privilege. Examines the boundaries of the privilege, what is and is not covered, how the privilege is protected and lost, and more. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 422947 422947 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/attorney-client-privilege-answer-book/397838?tCode=WTC5_RSS01 Attorney-client privilege Q&A guidance on the issues attorneys frequently grapple with regarding the attorney-client privilege. Examines the boundaries of the privilege, what is and is not covered, how the privilege is protected and lost, and more. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 397838 397838 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/attorney-client-privilege-answer-book/343869?tCode=WTC5_RSS01 Attorney-client privilege Attorney-Client Privilege Answer Book is a practical resource for attorneys and clients seeking to understand the most significant privilege in the practice of law. The book, written in question-and-answer format, examines the boundaries of the privilege, providing guidance on issues that attorneys grapple with on a regular basis as to what is, and is not, covered by the privilege, and how the privilege is protected and lost. Among the topics receiving in-depth treatment are what constitutes an “attorney,” “client,” and “communication” for purposes of the privilege; choice-of-law issues; waiver; and exceptions to the privilege. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 343869 343869 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/expert-witness-answer-book/343450?tCode=WTC5_RSS01 Litigation Witnesses Expert witnesses Practical reference for successfully presenting and challenging expert testimony in federal and state courts. Includes chapters on specific types of legal actions, such as copyright, products liability and toxic tort cases, and specific types of experts, including engineers and forensic and economic experts. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 343450 343450 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/expert-witness-answer-book/422941?tCode=WTC5_RSS01 Litigation Witnesses Expert witnesses Practical reference for successfully presenting and challenging expert testimony in federal and state courts. Covers specific types of legal actions, such as copyright, products liability and toxic tort cases, and specific types of experts, including engineers and forensic and economic experts. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 422941 422941 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/insurance-regulation-answer-book/422960?tCode=WTC5_RSS01 Insurance Regulation, compliance, and enforcement (Insurance) Reinsurance Easy-to-use Q&A guide providing a high-level understanding of the significant legal and regulatory issues governing the insurance business in the United States. A valuable resource for understanding the increasingly important context of national and international developments. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 422960 422960 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/insurance-regulation-answer-book/32644?tCode=WTC5_RSS01 Insurance Regulation, compliance, and enforcement (Insurance) Reinsurance Insurance Regulation Answer Book provides a general overview of the significant legal and regulatory guidelines that govern the insurance business in the United States. While it is deliberately high-level, providing an introduction to a complex and constantly changing area of the law, Insurance Regulation Answer Book offers readers practical guidance designed to assist them to effectively uncover the legal implications of proposed actions so they can help maximize opportunities, minimize liabilities and reduce compliance costs.Completely up-to-date, this title covers the changes made by the Dodd-Frank Act and other recent statutory and regulatory changes. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 32644 32644 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/insurance-regulation-answer-book/370681?tCode=WTC5_RSS01 Insurance Regulation, compliance, and enforcement (Insurance) Reinsurance Easy-to-use Q&A guide providing a high-level understanding of the significant legal and regulatory issues governing the insurance business in the United States. A valuable resource for understanding the increasingly important context of national and international developments. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 370681 370681 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/business-liability-insurance-answer-book/370679?tCode=WTC5_RSS01 Insurance Business liability insurance Casualty insurance Regulation, compliance, and enforcement (Insurance) Concise roadmap to the kinds of business issues being litigated and the types of liability insurance available to protect against suit and cover losses, including what is probably the hottest area of claims litigation now and in the future: cyber insurance. Loaded with highlighted Practice Pointers. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 370679 370679 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/business-liability-insurance-answer-book/422948?tCode=WTC5_RSS01 Insurance Business liability insurance Casualty insurance Regulation, compliance, and enforcement (Insurance) Concise roadmap to the kinds of business issues being litigated and the types of liability insurance available to protect against suit and cover losses, including what is probably the hottest area of claims litigation now and in the future: cyber insurance. Loaded with highlighted Practice Pointers. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 422948 422948 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/foreign-account-tax-compliance-act-answer-book/370668?tCode=WTC5_RSS01 Regulation, compliance, and enforcement (Banking and finance) Regulation, compliance, and enforcement (International law) Tax treaties Tax Regulation, compliance, and enforcement (Tax) Comprehensive, detailed analysis in Q&A format of FATCA, its terms and concepts, the obligations it imposes on foreign financial institutions and non-financial foreign entities, and the status of FATCA implementation globally. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 370668 370668 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/foreign-account-tax-compliance-act-answer-book/422956?tCode=WTC5_RSS01 Regulation, compliance, and enforcement (Banking and finance) Regulation, compliance, and enforcement (International law) Tax treaties Tax Regulation, compliance, and enforcement (Tax) Comprehensive, detailed analysis in Q&A format of FATCA, its terms and concepts, the obligations it imposes on foreign financial institutions and non-financial foreign entities, and the status of FATCA implementation globally. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 422956 422956 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/intellectual-property-law-answer-book/343261?tCode=WTC5_RSS01 Intellectual property Trademarks Patents Copyright Technology Intellectual Property Law Answer Book is an easy-to-use resource for practitioners facing a patent, trademark, or copyright issue. Written in a Q&A format, this book answers practical questions, helping readers to understand and address intellectual property issues that may arise in a transaction or litigation. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 343261 343261 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/intellectual-property-law-answer-book/396689?tCode=WTC5_RSS01 Intellectual property Trademarks Patents Copyright Technology An verview of patent, trademark, and copyright law in clear, concise question-and-answer format. Covers fundamental IP concepts, relevant procedures of the U.S. PTO and Copyright Office, basic statutes, and controlling precedents. With case studies, sample documents, charts, and practice tips. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 396689 396689 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/corporate-compliance-answer-book/422957?tCode=WTC5_RSS01 Regulation, compliance, and enforcement (Corporate law) Internal investigations (Corporate law) Regulation, compliance, and enforcement (International law) Litigation Q&A guide to compliance programs generally (risk assessment, internal investigations, records management, e-discovery, data privacy, witness prep, voluntary disclosure, etc.), and compliance in specific industries (healthcare, securities, higher education, consumer product safety, and more). Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 422957 422957 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/corporate-compliance-answer-book/47831?tCode=WTC5_RSS01 Regulation, compliance, and enforcement (Corporate law) Internal investigations (Corporate law) Regulation, compliance, and enforcement (International law) Litigation PLI’s Corporate Compliance Answer Book (Thirteenth Edition) provides clear guidance on a broad range of compliance and enforcement risks facing companies operating in heavily regulated industries. It explains the requirements of an effective compliance and ethics program, how it should be constructed and operate, and what issues and risks the program must address. It provides best practices in conducting internal investigations and responding to government enforcement activities. Importantly, it helps educate management and the board as to why your company needs a robust program. Presented in a clear, easy-to-use Q&A format, this two-volume set is loaded with dozens of case studies, invaluable compliance facts and tips, checklists, charts, and tables, providing the targeted guidance you need to design, implement, and enforce compliance programs that detect and prevent both intentional and unintentional wrongdoing and minimize the legal and financial damage violations can cause. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 47831 47831 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/corporate-compliance-answer-book/370680?tCode=WTC5_RSS01 Regulation, compliance, and enforcement (Corporate law) Internal investigations (Corporate law) Regulation, compliance, and enforcement (International law) Litigation Q&A guide to compliance programs generally (risk assessment, internal investigations, records management, e-discovery, data privacy, witness prep, voluntary disclosure, etc.), and compliance in specific industries (healthcare, securities, higher education, consumer product safety, and more). Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 370680 370680 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/erisa-benefits-litigation-answer-book/343867?tCode=WTC5_RSS01 Employee benefits Employee benefits litigation ERISA Benefits Litigation Answer Book provides a comprehensive overview of the various causes of action the Employee Retirement Income Security Act provides to remedy violations of the statute, enforce the terms of a benefit plan, or provide other relief to a plan, its participants or its fiduciaries. It describes the legal requirements of, defenses to, and unique aspects of litigation involving: stock drops, ESOPs, cash balance plans, prohibited transactions, 401(K) fees, recovery of benefits due under a plan, multi-employer plans, managed care plans, and discrimination and interference with benefits rights. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 343867 343867 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/erisa-benefits-litigation-answer-book/397843?tCode=WTC5_RSS01 Employee benefits Employee benefits litigation Provides an overview of the causes of action available under ERISA, including the requirements, defenses, and unique aspects of each type of action. Covers topics such as ESOPs, prohibited transactions, 401(K) fees, multi-employer plans, and managed care plans. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 397843 397843 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/maritime-law-answer-book/397363?tCode=WTC5_RSS01 Commercial law Maritime law Covers the specific issues that impact vessel owners, vessel bankers, and shippers of goods, and the issues that arise generally in maritime disputes, such as choice of law and limitation of liability. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 397363 397363 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/maritime-law-answer-book/343428?tCode=WTC5_RSS01 Commercial law Maritime law Maritime Law Answer Book provides answers to maritime law questions facing specialists and non-specialists alike, addressing issues that impact vessel owners, vessel bankers, and shippers of goods. Beyond examining traditional issues that arise in maritime disputes, such as choice of law and limitation of liability, this resource covers an array of U.S. regulatory issues ranging from promotional programs, such as the Maritime Security Program and coastwise trade regulation, to vessel financing considerations, environmental protection regulations, and criminal enforcement. While the book focuses on U.S. law and practice, it includes some reference to U.K. law, which has significant influence on many practices, leases, and financial transactions.   Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 343428 343428 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/sec-compliance-and-enforcement-answer-book/422969?tCode=WTC5_RSS01 Regulation, compliance, and enforcement (Corporate law) Securities and other financial products Regulation, compliance, and enforcement (Securities and other financial products) Expert Q&A guide to SEC practices and procedures and securities law. Covers how to conduct effective internal investigations, respond to the SEC, cooperate with Staff, negotiate resolutions, and litigate; the Wells process; and issues involving criminal and international law enforcement authorities. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 422969 422969 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/sec-compliance-and-enforcement-answer-book/319574?tCode=WTC5_RSS01 Regulation, compliance, and enforcement (Corporate law) Securities and other financial products Regulation, compliance, and enforcement (Securities and other financial products) Expert Q&A guide to SEC practices and procedures and securities law. Covers how to conduct effective internal investigations, respond to the SEC, cooperate with Staff, negotiate resolutions, and litigate; the Wells process; and issues involving criminal and international law enforcement authorities. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 319574 319574 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/transfer-pricing-answer-book/343323?tCode=WTC5_RSS01 Corporate tax International tax Cross-border transactions Regulation, compliance, and enforcement (Tax) The phenomenon of increasingly global business enterprises with valuable intangible property exposes companies to transfer pricing enforcement by different countries around the world. In light of the high-dollar risks presented by these increased enforcement efforts, the complexity of the ever-changing, inherently uncertain transfer pricing standards, and the continually evolving business models of businesses adapting to the constantly changing global economy, companies need practical guidance to permit them to develop and defend their transfer pricing strategies.Transfer Pricing Answer Book gives companies such guidance by discussing all aspects of transfer pricing, from the OECD’s proposal to modify international tax rules to address large-scale companies in digital commerce to the IRS Exam team’s selection of the best method for determining the arm’s-length result for taxpayer’s controlled transactions. The book’s non-technical discussion is presented in a question-and-answer format that will appeal to readers regardless of their prior level of experience or familiarity with taxes in general and transfer pricing in particular.The digital edition of Transfer Pricing Answer Book now includes a CPE self-study module, offering accounting professionals a convenient way to earn Continuing Professional Education (CPE) credit.Course Overview:The chapters comprising this QAS Self-Study Program will focus on:The key players in transfer pricing issues, including the IRS, foreign taxing authorities, and those on Capitol Hill and within the Treasury.The fundamentals of reporting obligations for multinational corporations pursuant to IRC §6038, including country-by-country reporting and records maintenance for multinational entities (MNEs)The fundamentals and impact of OECD’s BEPS initiative, including Pillar One and Pillar Two CPE Program Level:  OverviewIntended Audience: CPAs, tax accountants, tax lawyers, in-house tax professionals, taxpayers, government attorneys, and others seeking the latest information on current issues surrounding transfer pricing and navigating an audit in that context.Prerequisites: A basic understanding of IRS structure with respect to transfer pricing, the audit process, and the OECD’s BEPS initiative. Advanced Preparation: A background in international tax, accounting, economics, and law.Instructional Method:  QAS Self-StudyUpdated: June 2025Credit Information: 2 CPE credits are available upon completion of this program’s 6 content-review questions and a minimum passing score of 70% on the 10-question final exam. The CPE exam is required in accordance with NASBA Standard 9 – 04. You have unlimited retakes and up to one year to access this exam and achieve a passing score for CPE credit.View PLI's National Registry Statement.  Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 343323 343323 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/transfer-pricing-answer-book/369186?tCode=WTC5_RSS01 Corporate tax International tax Cross-border transactions Regulation, compliance, and enforcement (Tax) Easy-to-use Q&A guide on the U.S. laws regulating the pricing of transfers of property and services, including transfers of intangible property, among affiliated entities that operate as part of a multinational enterprise. Clear, accessible guidance for every practitioner grappling with the challenges of transfer pricing compliance. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 369186 369186 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/transfer-pricing-answer-book/422968?tCode=WTC5_RSS01 Corporate tax International tax Cross-border transactions Regulation, compliance, and enforcement (Tax) Q&A guide on U.S. laws regulating the pricing of transfers of property and services, including transfers of intangible property, among affiliated entities that operate as part of a multinational enterprise. Clear, accessible guidance for every practitioner grappling with transfer pricing compliance. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 422968 422968 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/depositions-answer-book/317402?tCode=WTC5_RSS01 Litigation Depositions Practice skills (Litigation) A valuable resource for in-house counsel in handling corporate criminal and regulatory matters. Examines both process issues—including corporate compliance, internal investigations, and government leniency programs—and substantive law, such as the False Claims Act, the Foreign Corrupt Practices Act, pharmaceutical drug offenses, criminal antitrust, perjury statutes, and money laundering. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 317402 317402 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/depositions-answer-book/422939?tCode=WTC5_RSS01 Litigation Depositions Practice skills (Litigation) Offers practical guidance on all stages of the deposition, from planning and preparation to post-deposition issues. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 422939 422939 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/medical-devices-law-and-regulation-answer-book/343859?tCode=WTC5_RSS01 Enforcement (Health care) Regulation, compliance, and enforcement (Health care) Regulation, compliance, and enforcement (Intellectual property) Medical devices Regulation, compliance, and enforcement (Life sciences) Regulation, compliance, and enforcement (Technology) Medical Devices Law and Regulation Answer Book walks you through the current regulatory requirements governing medical devices and describes every aspect from pre-market requirements for specific types of devices to post-market regulation and ongoing government enforcement and investigation. The organization of this text broadly follows the typical life cycle of a device and covers a broad range of topics, including many that are not commonly included in surveys of this field. Coverage includes the legal framework of FDA regulation of medical devices; clinical trials; COVID-19 policies; manufacturing compliance; the Quality System Regulation; and interacting with FDA and government enforcement and device commercialization and related issues.With contributions from more than two dozen of the world’s leading experts in medical device regulation, this comprehensive work distills the complexities of FDA medical device regulation into a single practical guide that will be of value to virtually everyone doing business in the medical device sector — including lawyers, consultants, companies operating in the medical device sector, and individual or entity contemplating entry into this field. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 343859 343859 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/medical-devices-law-and-regulation-answer-book/397728?tCode=WTC5_RSS01 Enforcement (Health care) Regulation, compliance, and enforcement (Health care) Regulation, compliance, and enforcement (Intellectual property) Medical devices Regulation, compliance, and enforcement (Life sciences) Regulation, compliance, and enforcement (Technology) Insights from leading experts in medical device law and regulation in a single comprehensive guide to this heavily regulated field. Answers the many common and far-ranging questions that arise when dealing with this complex system of overlapping and competing regulatory requirements. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 397728 397728 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/private-clients-legal--tax-planning-answer-book/343858?tCode=WTC5_RSS01 Estate planning Gift tax Last will and testament Tax Tax planning and strategy Private Clients Legal & Tax Planning Answer Book provides practical guidance for estate planning for individuals.This Q&A resource addresses complex client questions related to the benefit and protection of the client’s assets, dispositions to current and future family members, the uses of trusts and other vehicles, and current and future charitable donations.Authored and edited by G. Warren Whitaker and a team of experts from Day Pitney LLP, this Answer Book discusses the different ways in which assets can be owned and transferred; best practices in executing wills and trusts; clear guidance on estate, gift, and generation-skipping transfer taxes; and answers questions about retirement accounts, charitable giving, and family and marital issues.Stockpiled with highlighted practice tips, Private Clients Legal & Tax Planning Answer Book also provides guidance on issues related to incapacitation, international concerns, and managing the estate planning team (attorneys, accountants, trust officer, etc.) Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 343858 343858 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/private-clients-legal--tax-planning-answer-book/397727?tCode=WTC5_RSS01 Estate planning Gift tax Last will and testament Tax Tax planning and strategy Q&A resource for professionals involved in the present and future management of an individual’s assets, including during incapacity and after the individual’s death. Practical guidance on wills, trusts, taxes, insurance, retirement accounts, marital/family issues, charitable giving, and more. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 397727 397727 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/health-care-mergers-and-acquisitions-answer-book/343945?tCode=WTC5_RSS01 Regulation, compliance, and enforcement (Antitrust) Mergers and acquisitions Health care Regulation, compliance, and enforcement (Health care) Regulation, compliance, and enforcement (Life sciences) Regulation, compliance, and enforcement (Tax) M&A activity in the health care industry is at its highest level since the 1980s. Health Care Mergers and Acquisitions Answer Book, co-edited by Andrew L. Bab and Kevin A. Rinker at Debevoise & Plimpton LLP, provides the reader with a roadmap to this booming sector. Organized into four parts, it includes practical advice on how to address the various industry-specific issues arising in health care acquisitions:Part I: Structuring Health Care M&A Transactions focuses on the various legal and practical areas that can have an impact on the structure of a health care M&A transaction, including provisions relating to purchase price, as well as regulatory, antitrust, financing, and tax and accounting considerationsPart II: Due Diligence, discusses how to conduct diligence in health care transactions, including with regard to the regulatory and compliance issues arising in health care transactions, such as compliance with the federal and state health care fraud and abuse laws, Medicare and Medicaid rules, HIPAA and other health care regulations. Other topics discussed include intellectual property rights, material contracts, and product liability and medical malpractice claimsPart III: Transaction Documentation, analyzes the principal elements of a purchase agreement for a health care transaction, including industry specific representations and warranties, pre- and post-closing covenants, closing conditions, and indemnification provisions typically found in health care acquisition agreementsPart IV: Special Topics covers special issues arising in acquisitions of U.S. companies by non-U.S. buyers, as well as an overview of health care M&A transactions in France, Germany, England, Russia, and CanadaHealth Care Mergers and Acquisitions Answer Book analyzes recent health care transactions, and provides practice tips on what to look out for and how to avoid the various pitfalls that may be encountered while working on health care transactions. It covers dealmaking involving pharmaceutical and biotech companies, hospitals, health insurers and private equity and financial services firms investing in the health care sector. In addition to transactions involving outright acquisitions of health care companies, Health Care Mergers and Acquisitions Answer Book reviews alternative structures used in health care M&A transactions, such as: joint ventures • strategic alliances • product and portfolio acquisitions • option transactions, and • licensing and collaboration agreements. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 343945 343945 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/health-care-mergers-and-acquisitions-answer-book/397731?tCode=WTC5_RSS01 Regulation, compliance, and enforcement (Antitrust) Mergers and acquisitions Health care Regulation, compliance, and enforcement (Health care) Regulation, compliance, and enforcement (Life sciences) Regulation, compliance, and enforcement (Tax) M&A lawyers health law specialists, and corporate lawyers, —will profit from the insights of experts, distilled into concise questions and answers. Covers industry trends, structuring transactions, due diligence, drafting documents, and health care M&A in selected foreign jurisdictions. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 397731 397731 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/telecommunications-law-answer-book/343868?tCode=WTC5_RSS01 Communications and telecommunications Regulation, compliance, and enforcement (Communications and telecommunications) Covers duties of carriers, antitrust issues, broadband regulations and policies, regulation of mass media, social media, ADA requirements, privacy and data security, foreign ownership and participation, FCC equipment rules, political broadcasting rules, and services on U.S. Indian tribal lands. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 343868 343868 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/financially-distressed-companies-answer-book/343413?tCode=WTC5_RSS01 Financial distress Distressed companies Bankruptcy and restructuring Bankruptcy process Involuntary bankruptcy Regulation, compliance, and enforcement (Securities and other financial products) Financially Distressed Companies Answer Book provides a broad overview of topics relating to financially distressed companies. It is intended to be an easy reference with respect to issues for the management of a company finding itself in financial distress, a vendor or other creditor trying to manage its exposure or understand a bankruptcy process, or a nonbankruptcy lawyer needing a description of the legal concepts relevant to distressed companies. The book provides answers detailed enough to provide a working understanding of concepts, and relevant statutory and case law cites to facilitate any necessary further reading. Examples and practice tips help illustrate concepts and provide practical guidance. Topics discussed in Financially Distressed Companies Answer Book include: Control liability for pension plan obligationsWhether a creditor can file an involuntary bankruptcy petition against a financial distressed companyA bankruptcy court’s use of the principles of comityThe roles and fiduciary duties of directors and management in distress situationsRights and limitations of creditors in dealing with companies in distress and in bankruptcyConcepts and considerations relating to out-of-court restructuringsCross-border reorganizations and issues in international restructuringsKey concepts in U.S. bankruptcy cases; illustrative timelines to help guide strategic planningPractice and cautionary tips to provide guidance on issues such as how to recognize financial distress, when the securities laws might require disclosure, and what actions a creditor may take to protect its rights or limit its exposure Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 343413 343413 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/financially-distressed-companies-answer-book/397362?tCode=WTC5_RSS01 Financial distress Distressed companies Bankruptcy and restructuring Bankruptcy process Involuntary bankruptcy Regulation, compliance, and enforcement (Securities and other financial products) Q&A reference to issues related to management of a company that finds itself in financial distress, a vendor or other creditor trying to manage exposure or understand the bankruptcy process, or non-specialist seeking an understanding of the relevant legal concepts. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 397362 397362 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/financial-institutions-answer-book-law-governance-compliance/319565?tCode=WTC5_RSS01 Financial institutions Regulation, compliance, and enforcement (Banking and finance) Regulation, compliance, and enforcement (Corporate law) Regulation, compliance, and enforcement (Securities and other financial products) Financial Institutions Answer Book provides, in a handy Q&A format, a comprehensive overview of the complex federal requirements regulating financial institutions in the United States. Every aspect of a financial institution life cycle is covered, from understanding the differences in regulation based on what type of charter is chosen, through ongoing capital and deposit activities requirements and major changes in corporate control, to the cessation of entity activity through merger, acquisition or entity failure. Financial Institutions Answer Book describes the requirements under each type of charter for the major areas of financial institution activity, such as: The creation of branch offices and deposit activityCorporate governanceExecutive compensationDeposit insurance requirementsInsider and affiliate transactionsAnti-money laundering and U.S. trade sanctionsExamination and auditPrivacy and data security Reflecting the increased federal concern with fraud, money laundering and protecting the federal taxpayer from bank defaults, individual chapters are devoted to describing in detail the federal enforcement agencies and their powers, anti-money laundering and other fraud issues, the required examinations and audit process, and recent regulatory approaches to problem banks and failure. Published in a handy softcover volume, Financial Institutions Answer Book is a source for quick, concise answers and will be of interest to lawyers and other legal professionals, as well as financial institution managers, officers, directors and other employees who would like a comprehensive understanding of the legal framework regulating banks and other financial institutions. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 319565 319565 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/financial-institutions-answer-book-law-governance-compliance/396688?tCode=WTC5_RSS01 Financial institutions Regulation, compliance, and enforcement (Banking and finance) Regulation, compliance, and enforcement (Corporate law) Regulation, compliance, and enforcement (Securities and other financial products) Addresses the continuing changes in the laws, rules, and regulations to implement the provisions of the Dodd-Frank Act that apply to financial institutions. Provides guidance to attorneys as well as the wider corporate community in the areas of financial services and financial institutions. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 396688 396688 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/labor-management-law-answer-book/319349?tCode=WTC5_RSS01 Employment and labor Labor relations Labor unions Presents an overview of the NLRA and other major federal labor legislation, along with interpretative decisions by the NLRB and courts. Detailed guidance on the rights and obligations of employees, employers, and unions. Includes coverage of executive orders related to federal contractors. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 319349 319349 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/consumer-financial-services-answer-book/370669?tCode=WTC5_RSS01 Consumer finance Mortgage loans Financial services Unfair and deceptive, or abusive acts and practices Q&A guide to the laws governing consumer financial services. Coverage of the Consumer Financial Protection Bureau, auto finance, consumer bankruptcy, UDAAP statutes, credit cards, military lending, mortgage lending and servicing, credit reporting, electronic signatures, data privacy, and more. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 370669 370669 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/antitrust-law-answer-book/267618?tCode=WTC5_RSS01 Antitrust litigation Regulation, compliance, and enforcement (Antitrust) Corporate agreements Mergers and acquisitions Comprehensive overview for the non-expert who wants to understand the basic concepts of U.S. antitrust law. Addresses the most common business problems and emerging topics that illustrate the scope of the antitrust laws. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 267618 267618 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/international-trade-law-answer-book-u.s.-customs-laws-and-regulations/172681?tCode=WTC5_RSS01 International trade Presents the regulatory requirements for each step in the importation process, including how to submit relevant forms and how to handle a negative Customs response, from filing of protests to litigating disputes in the courts. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 172681 172681 167 0:00:00 https://www.pli.edu/catalog/publications/answer-book/financial-services-mediation-answer-book/212508?tCode=WTC5_RSS01 Financial services Financial services litigation Dispute resolution Mediation Perspectives from more than 40 of the nation’s top financial services attorneys and mediators. Strategic and tactical opportunities that mediation can offer to help structure a resolution that is often superior to a fully litigated outcome. Practising Law Institute 1177 Avenue of the Americas New York NY 10036 USA (800)260-4PLI info@pli.edu 212508 212508 167 0:00:00