| James P. Ellison and Anne K. Walsh’s FDA Deskbook: A Compliance and Enforcement Guide provides an in-depth discussion on recalls.
A firm conducting a recall must develop a recall strategy taking into account the results of the Health Hazard Evaluation (HHE), ease in identifying the product, the degree to which the product’s deficiency is obvious to the consumer or user, the degree to which the product remains unused in the marketplace, and the continued availability of essential products. FDA will review and approve the recall strategy of a recalling firm. The elements of a recall strategy are:
TO LEARN MORE ABOUT THE FDA, READ: FDA Deskbook: A Compliance and Enforcement Guide Edited by James P. Ellison and Anne K. Walsh (Hyman, Phelps & McNamara, P.C.)
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Category Archives: PLI Press
New Answer Book! Privacy Law Answer Book
PLI’s new Privacy Law Answer Book answers key questions related to the evolving collection, use, and storage of consumers’ personal information.
The Q&A-formatted guide makes clear sense of the patchwork of federal, state and international laws and regulations, with expert guidance on privacy policies, COPPA, financial privacy, medical privacy, and more.
Edited by Jeremy Feigelson (Debevoise & Plimpton LLP), the Answer Book will help readers keep clients and companies one step ahead of the data privacy challenges of tomorrow.
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.
New Treatise! A Starter Guide to Doing Business in the United States
A Starter Guide to Doing Business in the United States is a new “must read” for non-U.S. businesses, foreign attorneys, law firm associates and new entrepreneurs. Edited by Woon-Wah Siu (Pillsbury Winthrop Shaw Pittman LLP) the Starter Guide covers the main legal and regulatory issues to be considered before entering the U.S. market, including:
- Choice of a business entity—describing the requirements for a corporation, LLC, partnership, and sole proprietorship
- Federal securities law—discusses the major statutes, provisions and regulations controlling the creation and exchange of business interests; the chapter includes what is required to qualify as a Foreign Private Issuer
- Buying a company: the M&A process—highlighting each step of the process and the differences between buying a U.S. company and a non-U.S. company
- Employment considerations—providing general guidance on the issues and statutes that arise when hiring employees in the U.S.
- Equity incentives for U.S. employees—comparing the permissible types of equity incentives and the related, relevant tax and accounting treatment of such incentives
- Immigration law—describing the requirements for the various types of employment-related visas and other business-related provisions
- U.S. international trade law—exploring, in the book’s most extensive chapter, the many major statutes and international agreements that regulate importing into, exporting out of, or investing in the United States
- Protecting intellectual property—describing the kinds of protections in the U.S. and how to derive maximum value from your IP through licensing, and how to assert or defend your IP in litigation
- Environmental law—describing the requirements mandated by major federal and state statutes and regulations, as well as providing suggestions on successful compliance strategies
- Taxation—describing the many kinds of taxes affecting trade and business, and focusing on the distinctions between how U.S. persons versus non-U.S. persons, as well as U.S. source versus non-U.S. source income, are treated
- Litigation before courts and agencies, mediation and arbitration—providing a general discussion of the structure of the court systems in the United States as applied to civil cases, the terminology and procedure generally used in U.S. courts, enforcement of court judgments, and specialized tribunals, arbitration and mediation.
The Starter Guide also includes concepts in U.S. commercial real estate transactions, regulation of the energy sector, products liability law, and business insurance. This new guide also provides useful charts, tables, best practices and highlighted tips.
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.
PLI Discover PLUS Answer Books Video Tutorial
PLI Answer Books are written in an easy to read, q&a format. And they’re filled with checklists and practice pointers, making them useful resources for seasoned practitioners and newer attorneys alike. Watch this short video tutorial to learn how to access our more than 80 Answer Books on PLI Discover PLUS:
Be sure to check out the rest of our videos on the PLI Librarian YouTube channel. We will continue to add instructional videos to this channel, so stay tuned for more! And if you have any suggestions on search tips videos you would like to see, please contact the PLI Library Help Desk .
What’s New on Discover PLUS for May
We add content to PLI Discover PLUS every month to ensure our subscribers have access to the most up-to-date and relevant secondary source legal documents. Renowned legal experts regularly updated our acclaimed Treatises, Course Handbooks, Answer Books, Transcripts and Forms to reflect recent changes and developments in the law.
Click here to see what we added in May.
New Treatise! FDA Deskbook: A Compliance and Enforcement Guide
FDA 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.
Law Day Sale!
Happy Law Day! To celebrate, we’re offering 40% off all PLI Answer Books and Treatises until midnight tonight:
Last Day – National Library Week Book Sale!
In celebration of National Library Week, Practising Law Institute is offering a 20% discount on all Treatises and Answer Books from April 10 – 16. Today is the last day of our sale!
Prefer to do your research digitally? We encourage you to access our publications online through a subscription to PLI’s research database, Discover PLUS. Discover PLUS gives you access to our Course Handbooks, Treatises and Answer Books, in addition to over 3,000 downloadable forms and close to 1,000 program transcripts.
Trial Handbook Spring 2016 Edition Now Available
The S
pring 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!
New Answer Book! Private Clients Legal & Tax Planning Answer Book 2016
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!