HEALTH CARE AND LIFE SCIENCES / EMPLOYEE BENEFITS
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.)
ERISA BENEFITS LITIGATION ANSWER BOOK
Edited by Craig C. Martin and Amanda S. Amert (Willkie Farr & Gallagher LLP)
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. Stay up to date on ERISA developments with PLI’s Upkeep Service. 1 softbound volume or digital, 452 pages, $366, Item #397843, ISBN 978-1-4024-4616-0, Published as needed
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 supplements, tobacco, animal products, and cosmetics. Track FDA developments with PLI’s Upkeep Service.
1 looseleaf volume, 1,084 pages, $514, Item #173127, ISBN 978-1-4024-2647-6, Updated annually or as needed
ERISA DEPARTMENT OF LABOR INVESTIGATIONS AND LITIGATION Theresa S. Gee, Dawn E. Murphy-Johnson, Joanne Roskey, and Anthony F. Shelley (Miller & Chevalier)
PHARMACEUTICAL COMPLIANCE AND ENFORCEMENT ANSWER BOOK Edited by Howard L. Dorfman (H.L. Dorfman Pharmaceutical Consulting)
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,
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, regulatory, and risk management issues. In addition to a sample FDA close-out letter that readers can reference, treatise owners will discover comprehensive conversational insights that, taken together, offer a roadmap to effective FDA pharmaceutical regulatory compliance. Follow new FDA initiatives with PLI’s Upkeep Service. 1 softbound volume or digital, 962 pages, $303, Item #397730, ISBN 978-1-4024-4604-7, Published annually or as needed
and DOL investigation and enforcement documents. Combat emerging DOL enforcement practices through PLI’s Upkeep Service. 1 softbound volume, 994 pages, $494, Item #373764, ISBN 978-1-4024-4378-7, Updated annually or as needed
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