Category Archives: New Title!

New Treatise! FDA Deskbook: A Compliance and Enforcement Guide

FDA DeskbookFDA Deskbook: A Compliance and Enforcement Guide provides a comprehensive description of the complexities of compliance under The Federal Food, Drug, and Cosmetic Act (FDC Act) and practical suggestions on how FDA-regulated entities can avoid being the subject of an enforcement action by the federal government.  This new title fully explains the legal framework created by the FDC Act and subsequent statutes, regulations, guidance and policies governing the food and drug industry.

Written by attorneys at Hyman, Phelps & McNamara, P.C., the largest dedicated food and drug law firm in the U.S., the FDA Deskbook incorporates more than a century of cumulative experience from positions at FDA, the U.S. Department of Justice, the Drug Enforcement Administration, U.S. Attorney’s Offices, and regulated industry.  The result is this essential guidebook, which aims to assist industry stakeholders by providing a wide-ranging review of compliance and enforcement under the FDC Act and related laws.

The FDA Deskbook first details the ins-and-outs of FDA’s administrative actions (such as warning letters, import alerts, and recalls) and civil and criminal enforcement authorities.  The FDA Deskbook then walks the reader through individual chapters highlighting specific issues affecting the cross-section of FDA regulation:

  • drugs, including OTC, prescription, and compounded drugs, and controlled substances
  • medical devices, including in vitro diagnostic devices
  • food and dietary supplements
  • tobacco
  • animal products
  • cosmetics

Importantly, the FDA Deskbook contains chapters focused on today’s hot button issues, such as advertising and promotion, fraud and abuse, and good manufacturing practices.  The FDA Deskbook proposes best practice tips, including how to deal with FDA inspections, alternatives to conducting internal investigations, and potential defense strategies for use in enforcement proceedings.

The FDA Deskbook provides a thorough discussion of the current landscape necessary for FDA-regulated entities to achieve compliance and avoid enforcement action.

This essential new title is available on PLI Discover PLUS, our online research database. If you’d like to order a print copy, please email the PLI Library Help Desk or call 877-900-5291.

Trial Handbook Spring 2016 Edition Now Available

The STrial Handbook Spring 2016pring 2016 edition of The Trial Handbook is now available in print and on PLI Discover PLUS, our online research database!

Trial Handbook is the one-stop resource you can trust in the planning, trial, and post-trial stages of litigation. Designed for quick reference in the courtroom, Trial Handbook is keyed to the Federal Rules of Evidence and focuses on the presentation of proof and the evidentiary problems faced by counsel.

Packed with practical checklists, charts, outlines, sample jury selection questions, Trial Handbook gives you the knowledge and tools to:

  • Develop solid trial briefs and strong case plans
  • Prepare lay and expert witnesses and organize your exhibits more effectively
  • Master voir dire to maximize your chances of getting the most sympathetic jurors
  • Make a clear record at trial to aid jurors’ understanding of your case
  • Build a rapport and your credibility with the jury throughout the trial
  • Use opening statements to put your cases, clients, and proof in the most favorable light
  • Give summations that blend evidence and issues to paint a thoroughly persuasive picture
  • Exploit discovery materials at trial to get an additional edge
  • Lay the proper foundation for various forms of evidence
  • Capitalize on the powerful probative impact of visual aids at trial
  • Apply proven direct examination and cross-examination techniques
  • Use pretrial, trial, and post-trial motions to gain strategic advantages
  • Draft clear, legally sound jury instructions that subtly sway judges

At the heart of Trial Handbook is its unique Evidence Guide, now also included as a laminated fold-out, which clearly explains the meaning, purpose, operation, and history of every rule, including how each rule applies to other cases and how leading cases construe a particular rule.

Volume 2, the Case Authority, includes thousands of case summaries of decisions under the rules, arming you with the latest evidentiary resources to help you prevail at trial.

Interested in our other Litigation resources?  Check out our Litigation Research Center below!

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New Answer Book! Private Clients Legal & Tax Planning Answer Book 2016

Private Clients Answer Book

Private Clients Legal & Tax Planning Answer Book 2016 provides practical guidance for estate planning for individuals.

This new 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 new 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 on retirement accounts, charitable giving, and family and marital issues.

Stockpiled with highlighted practice tips, Private Clients Legal & Tax Planning Answer Book 2016 also provides guidance on issues related to incapacitation, international concerns, and managing the estate planning team (attorneys, accountants, trust officer, etc.)

If you’d like to order Private Clients Legal & Tax Planning Answer Book 2016 or view it on PLI Discover PLUS, please email the PLI Library Help Desk or call 877-900-5291.

Interested in our other Tax resources?  Check out our Tax Research Center below!

The Daily Record Highlights PLI’s Cybersecurity: A Practical Guide to the Law of Cyber Risk

PCybersecurityLI’s Cybersecurity: A Practical Guide to the Law of Cyber Risk  was recently mentioned in The Daily Record, which you can view here.  The Treatise is available for purchase here and is also accessible online on our digital research platform, PLI Discover PLUS. Interested in learning more about this book or PLI Discover PLUS? Contact PLI’s Library Relations team at PLI Library Relations or call 877-900-5291.

Daily Record Article on Cybersecurity: A Practical Guide to the Law of Cyber Risk  

Practising Law Institute, the New York-based nonprofit that specializes in continuing legal education, announced the publication Wednesday of what it describes as the firs major legal treatise on the law of cyber risk.

PLI says the new work, Cybersecurity: A Practical Guide to the Law of Cyber Risk, reflects a new reality.

“Managing cyber risks, once the near-exclusive realm of IT professionals, is now also borne by attorneys, senior executives, and directors,” PLI said in a press release. “This new guide provides the practical steps that can be taken to understand and mitigate today’s cyber risks and build the most resilient response capabilities possible.”

The editors are Edward R. McNicholas and Vivek K. Mohan of Sidley Austin LLP’s Privacy, Data Security and Information Law practice group. Both are based in Washington, D.C.

PLI says the book provides a comprehensive discussion of the complex quilt of federal and state statutes, executive orders, regulations and contractual norms, as well as the ambiguous tort duties that can apply.

The book, which costs $395, includes practice tools developed during the hundreds of breaches that the authors have weathered with their clients.

 

New Treatise! Cybersecurity: A Practical Guide to the Law of Cyber Risk

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The many recent sophisticated cyber threats—from hacktivists and empowered insiders to organized criminals and state-sponsored cyber attacks—means that the task of managing cyber risks, once the near-exclusive realm of IT professionals, is now also borne by attorneys, senior executives, and directors. PLI’s new Cybersecurity: A Practical Guide to the Law of Cyber Risk provides the practical steps that can be taken to help your clients understand and mitigate today’s cyber risk and to build the most resilient response capabilities possible.

Cybersecurity: A Practical Guide to the Law of Cyber Risk provides a comprehensive discussion of the complex quilt of federal and state statutes, Executive Orders, regulations, contractual norms, and ambiguous tort duties that can apply to this crucial new area of the law. For example, it describes in detail:

  • The leading regulatory role the Federal Trade Commission has played, acting on its authority to regulate “unfair” or “deceptive” trade practices;
  • The guidance issued by the SEC interpreting existing disclosure rules to require registrants to disclose cybersecurity risks under certain circumstances;
  • The varying roles of other regulators in sector-specific regulation, such as healthcare, energy, and transportation; and
  • The impact of preexisting statutes, such as the Computer Fraud and Abuse Act and the Electronic Communications Privacy Act, on current cybersecurity issues.

In addition, the authors of Cybersecurity: A Practical Guide to the Law of Cyber Risk have supplemented these more traditional sources of law with industry practices and the most important sources of soft law:

  • An explanation of the National Institute of Standards and Technology (NIST) Cybersecurity Framework and information sharing environments from a former Department of Homeland Security official,
  • The views of the U.S. Secret Service on partnering with federal law enforcement and effective information-sharing,
  • The guidance of leading consultants about the appropriate steps to prepare for cybersecurity incidents,
  • The perspective of a leading insurance company on the evolving role of insurance in protecting companies from the financial losses associated with a successful cyber breach, and
  • The views of one of the most sophisticated incident response organizations on the proper elements of effective incident response.

Throughout the book, Cybersecurity: A Practical Guide to the Law of Cyber Risk includes practice tools developed during the hundreds of breaches that the authors have weathered with their clients. These valuable practice aids include checklists, an overview of the legal consequences of a breach, and a tabletop exercise.

If you’d like to order Cybersecurity: A Practical Guide to the Law of Cyber Risk, please email the PLI Library Help Desk or call 877-900-5291.

 

New Titles Added From January 2014 – July 2015

Discover PLUS is PLI’s eBook library, which provides unlimited access to Treatises, Course Handbooks, and Answer Books, in addition to Legal Forms and Program Transcripts. To reflect recent changes and the latest in legal developments, Discover PLUS is updated continuously with supplements and new editions as well as completely new titles. This is a list of the new titles added from January 2014 – July 2015.

New Titles 2014 – 2015

 

 

NEW Answer Book! SEC Compliance and Enforcement Answer Book 2015

Titles-7775-SEC-Comp-Enforce-AB-2015_20150602102052Counsel to broker-dealers, investment advisers, U.S.-registered issuers and other participants in the securities markets must have a thorough and clear understanding of the SEC’s enforcement mechanisms. PLI’s new SEC Compliance and Enforcement Answer Book 2015 is a comprehensive and concise reference book organized in an easy-to-use Q&A format.

Edited by David M. Stuart (Cravath, Swaine and Moore LLP), this expert Q&A guide compiles the perspectives of leading practitioners from around the country who have previously served in the SEC Enforcement Division, many of whom were in some of the most senior positions in the Division.

Leveraging the authors’ experience and expertise, SEC Compliance and Enforcement Answer Book 2015 provides nuts and bolts guidance on:

  • Conducting an effective internal investigation – while the SEC is simultaneously investigating
  • Responding to SEC requests and subpoenas for documents, interviews, and testimony
  • Cooperating effectively with SEC staff
  • The Wells process, negotiating resolutions, and litigating with the SEC
  • The complexities that arise when criminal and international law enforcement authorities becomes involved in an SEC investigation

Additionally, SEC Compliance and Enforcement Answer Book 2015 answers questions on insider trading, accounting and securities fraud, market manipulation and foreign corruption. The Q&A guide also tackles special issues related to investigations of attorneys, accountants, and those identified by whistleblowers.

If you’d like to order SEC Compliance and Enforcement Answer Book 2015, please email the PLI Library Help Desk or call 877-900-5291.  SEC Compliance and Enforcement Answer Book 2015 is also available on Discover PLUS .

 

New Treatise! Global Business Fraud and the Law: Preventing and Remedying Fraud and Corruption

AnotheTitles_7655_Global-Business-Fraud-and-the-Law_20150519154305r new PLI title has been added to Discover PLUS: Global Business Fraud and the Law: Preventing and Remedying Fraud and Corruption.

This brand-new book presents a comprehensive and practical guide to preventing business fraud and corruption, and remedying unlawful behavior should it occur. Expert practitioners from around the globe offer an international perspective based on their extensive experience.

Whether you run a company that operates across international borders or provide legal counsel to such a company, this book provides an invaluable resource.

Part I of Global Business Fraud and the Law explores the nuts and bolts of global compliance issues and potential for internal investigations that could confront organizations and individuals conducting international commerce.

Chapter 1 Design, Implementation, and Operation of Global Compliance Programs
Chapter 2 Considerations in Global Internal Investigations
Chapter 3 The Audit Committee’s Evolving Role in Overseeing Corporate Investigations
Chapter 4 Foreign Corrupt Practices Act
Chapter 5 Conducting an FCPA Internal Investigation
Chapter 6 Global Antitrust Cartel Enforcement: Identifying Risks and Ensuring Compliance
Chapter 7 The Economic Espionage Act
Chapter 8 International Intellectual Property Protection
Chapter 9 OFAC Enforcement of U.S. International Economic Sanctions

Part II provides country-specific practice guides to the law of business fraud and corruption in several countries key to global commerce:

Chapter 10 Brazil
Chapter 11 Russia
Chapter 12 India
Chapter 13 China
Chapter 14 Australia
Chapter 15 United States
Chapter 16 United Kingdom

If you’d like to order Global Business Fraud and the Law: Preventing and Remedying Fraud and Corruption, please email the PLI Library Help Desk or call 877-900-5291.