HEALTH CARE AND LIFE SCIENCES
HEALTH CARE AND LIFE SCIENCES / EMPLOYEE BENEFITS
Legal Guide to the Business of Cannabis and Hemp
Medical Devices Law and Regulation Answer Book Edited by Suzan Onel (Kleinfeld, Kaplan & Becker, LLP) and Karen M. Becker (Precision for Medicine)
Pharmaceutical Compliance and Enforcement Answer Book Edited by Howard L. Dorfman (H.L. Dorfman Pharmaceutical Consulting)
ERISA Benefits Litigation Answer Book Edited by Craig C. Martin and Amanda S. Amert (Willkie Farr & Gallagher LLP)
Edgar J. Asebey (Frier Levitt) and Guilherme Ferrari (Frier Levitt)
This helpful resource for practitioners, cannabis growers, retailers, and other players elucidates upon the regulatory pressures affecting cannabis, hemp, and cannabidiol businesses. This deskbook is authored by a pair of esteemed public health policy practitioners who have worked on varied projects and matters involving Food and Drug Administration compliance and public health matters. Cannabis stakeholders and advisers will find a plethora of case studies, practical insights, and in- depth guidance on the political and public policy issues that impact
This question-and-answer book offers detailed, comprehensive conversations on the pre-market requirements and post- market regulation affecting medical devices and their manufacturers. Readers will find insightful, easy-to-follow discussions from a group of esteemed health care lawyers and professors — all of whom have counseled clients on FDA compliance and enforcement matters. Anyone who counsels or works for a device manufacturer or health care regulatory agency will find instructive discussions of the premarket and post-market requirements
Presented in an easy-to- follow question-and-answer format, this title explores the regulatory issues that companies and stakeholders in the pharmaceutical industry face — along with their in-house and outside counsel. Readers will find helpful, grounded guidance from an author with extensive experience counseling pharmaceutical and biotechnology companies on a vast array of compliance,
This work 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. Also covered are chapters discussing litigation of claims arising under federal common law, affirmative defenses to ERISA claims, and limitations on actions under ERISA.
1 softbound volume or digital, 612 pages, $226, Item #423105, ISBN 978-1-4024-4821-8
regulatory, and risk management issues.
1 softbound volume or digital, 1,412 pages, $305, Item #397728, ISBN 978-1-4024-4611-5, Published annually or as needed
1 softbound volume or digital, 452 pages, $366, Item #397843, ISBN 978-1-4024-4616-0, Published as needed
1 softbound volume or digital, 914 pages, $315, Item #447832, ISBN 978-1-4024-4997-0, Published annually or as needed
Stay up to date on ERISA developments with PLI’s Upkeep Service.
In addition to a sample FDA close-out letter that readers can reference, treatise owners will discover comprehensive
them and their enterprises on the state and federal levels. Track important cannabis, hemp, and cannabidiol regulatory developments with PLI’s Upkeep Service.
and considerations around medical devices, including 3D-printed devices, devices used with regenerative therapies, combination products, restricted devices, custom devices, and radiological products. Keep up with new medical device requirements with PLI’s Upkeep Service.
conversational insights that, taken together, offer a roadmap to effective FDA pharmaceutical regulatory compliance. Follow new FDA initiatives with PLI’s Upkeep Service.
ERISA Department of Labor Investigations and Litigation Theresa S. Gee, Dawn E. Murphy-Johnson, Joanne Roskey, and Anthony F. Shelley (Miller & Chevalier)
FDA Deskbook A Compliance and Enforcement Guide Edited by James P. Ellison, John A. Gilbert, Jr., and Anne K. Walsh (Hyman, Phelps & McNamara, P.C.)
This treatise walks readers through litigation issues and strategies arising from the Employee Retirement Income Security Act (ERISA) — particularly those surrounding pension plans, which is the focus of much of the DOL’s enforcement work. The author has advised clients on diverse ERISA matters and offers practice-ready advice for employers, plan administrators, and the attorneys that advise them. This title serves as both a comprehensive reference of key DOL regulations and guidance and a go-to resource for the Department’s ever-evolving views on ERISA fiduciary responsibilities. Throughout its chapters, the book highlights cases the DOL has initiated as either a plaintiff or amicus — ranging from lower court matters to Supreme Court cases — and how subsequent court holdings and responses have impacted an employer’s fiduciary rights and liabilities. Also included are curated executive orders, strategic enforcement plans, and DOL investigation and enforcement documents. Combat emerging DOL enforcement practices through PLI’s Upkeep Service.
This Deskbook walks health care practitioners, company leaders, and professionals through the regulatory issues the FDC Act imposes on applicable companies. Readers will receive insights from practitioners with substantial experience around FDA, DEA, FTC, and other agency disputes. Readers will find comprehensive coverage of FDC Act compliance and legal considerations. In addition to covering FDA administrative actions, the authors address rules regarding medications, drugs, controlled substances, medical devices, in vitro diagnostic devices, food, dietary
1 softbound volume, 994 pages, $494, Item #373764, ISBN 978-1-4024-4378-7, Updated annually or as needed
supplements, tobacco, animal products, and cosmetics. Track FDA developments with PLI’s Upkeep Service.
1 looseleaf volume, 1,092 pages, $535, Item #173127, ISBN 978-1-4024-2647-6, Updated annually or as needed
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