Regulation of Pharmaceutical Manufacturers (Regulatory Series)

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9781588521651: Regulation of Pharmaceutical Manufacturers (Regulatory Series)

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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
Health Law
Securities and Federal Corporate Law

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Product Description:

Pharmaceutical companies are constrained by statutes, regulations, and advisory opinions covering all aspects of their business clinical trials, marketing practices, disclosure of drug side effects and manufacturing problems, and more. Regulation of Pharmaceutical Manufacturers, written by two nationally renowned practitioners, 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.

About the Author:

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.

Andrew T. Bayman is a partner at King & Spalding in Atlanta, Georgia. He is the Practice Group Leader of its Tort Litigation and Environmental Practice Group. It is is one of the largest practice groups of its kind and has been recognized by The American Lawyer as one of the country s top three product liability practices in the country. Mr. Bayman was ranked as a top defense lawyer in the nation in the Super Lawyers Corporate Counsel editions for 2009-2010. Mr. Bayman chairs King & Spalding s Pharmaceutical-Medical Device-Biotech industry practice initiative. He also served as the 2004-05 Chair of the State Bar of Georgia s Product Liability Section. He lectures frequently on on emerging issues in product liability litigation. He is a Phi Beta Kappa, magna cum laude graduate from Miami University in Oxford, Ohio and received his J.D. from Vanderbilt University School of Law where he was a Patrick Wilson Scholar and a member of the Vanderbilt Law Review.

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by Andrew T. Bayman/ and Chilton Davis Varner
Published by Law Journal Seminars Press (2012)
ISBN 10: 1588521656 ISBN 13: 9781588521651
New Hardcover Quantity Available: 1
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Revaluation Books
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Book Description Law Journal Seminars Press, 2012. Hardcover. Book Condition: Brand New. looseleaf edition. 14.60x8.30x7.50 inches. In Stock. Bookseller Inventory # 1588521656

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