PLI Publishes FDA Deskbook: A Compliance And Enforcement Guide

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May 16, 2016, 03:56 ET

NEW YORK, May 16, 2016 /PRNewswire-USNewswire/ -- Practising Law Institute (PLI) announces the release of their newest publication, FDA Deskbook: A Compliance and Enforcement Guide.

Written by attorneys at Hyman, Phelps & McNamara, P.C., FDA Deskbook covers the complexities of compliance under the Federal Food, Drug, and Cosmetic Act (FDC Act) and provides practical suggestions on how FDA-regulated entities can avoid being the subject of an enforcement action by the federal government.

Edited by James P. Ellison and Anne K. Walsh, the FDA Deskbook contains a thorough discussion of the current regulatory landscape and contains chapters focused on today's hot-button issues, such as advertising and promotion, fraud and abuse, and good manufacturing practices. The new book 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.

FDA Deskbook incorporates more than a century of cumulative experience from positions at the FDA, the U.S. Department of Justice, the Drug Enforcement Administration, U.S. Attorney's Offices, and regulated industry.

About Practising Law Institute (PLI) www.pli.edu

Practising Law Institute (PLI) is a nonprofit continuing legal education and professional business training organization, chartered by the Regents of the University of the State of New York. Founded in 1933 by Harold P. Seligson, PLI is dedicated to providing the legal community and allied professionals with the most up-to-date, relevant information and techniques, through seminars and workshops, live Webcasts, and On-Demand learning. PLI also publishes comprehensive treatises and practice-focused Course Handbooks in print and through Discover PLUS, its searchable eBook library and research database. PLI holds programs in its offices in New York and California, and elsewhere throughout the U.S., as well as in London, Hong Kong and Latin America. PLI annually awards more than 60,000 scholarships to its programs, and its more than 4,000 speakers include the most prominent lawyers, judges, investment bankers, accountants, corporate counsel, and U.S. and international regulators.

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SOURCE Practising Law Institute