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Regulation of Pharmaceutical Manufacturers is the complete, multidisciplinary guide to the field. Written by two nationally renowned practitioners, it examines the legal and practical considerations involved in handling any issue that may arise, civil or criminal.
Topics include: FDA regulation of clinical trials and the drug approval process; regulation of controlled substances and listed chemicals; intellectual property law protection of pharmaceutical research; pharmaceutical company mergers; insurance law issues affecting pharmaceutical companies; parent company liability for acts of a subsidiary or for prior acts of an acquired company; off-label promotion, kickbacks and illegal marketing practices; whistleblower suits; product liability issues unique to pharmaceuticals and medical devices; tort claims by third party payors and defenses; securities law disclosure; class actions; and more.
Regulation of Pharmaceutical Manufacturers covers current law and regulation as well as the latest enforcement actions and civil and criminal settlements a must when advising clients. The pharmaceutical lawyer who consults this valuable guide will have an advantage when facing any challenge.
Practice Area: Administrative Law
Securities and Federal Corporate Law
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Chilton Davis Varner is a partner in King & Spalding in Atlanta, Georgia. She has 30 years of courtroom experience as a trial lawyer defending a number of the country s largest, pharmaceutical and medical device manufacturers in mass tort litigation, class actions and MDL litigation. She was identified by the National Law Journal as one of the countryrsquo;s top ten women litigators and is the senior partner in a product liability practice selected by Chambers as one of the best in the country. Ms. Varner was appointed by Chief Justice Rehnquist in 2004 and re-appointed by Chief Justice Roberts in 2007 to the Federal Civil Rules Advisory Committee. She has written and lectured widely on legal issues. Ms. Varner is a Phi Beta Kappa graduate of Smith College, Northampton, Massachusetts and received her J.D., with distinction, Order of the Coif, from Emory University School of Law.
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Book Description Law Journal Seminars Press, 2010. Condition: New. book. Seller Inventory # M1588521656
Book Description Law Journal Seminars Press, 2010. Hardcover. Condition: New. Lslf. Ships with Tracking Number! INTERNATIONAL WORLDWIDE Shipping available. Buy with confidence, excellent customer service!. Seller Inventory # 1588521656n