Regulation of Pharmaceutical Manufacturers
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*New All-Inclusive Annual Service Pricing—This title now includes free online access for 1 year to a digital version in addition to the print version. Pricing includes an entire year of Updates. See below for more details.
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 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.
*Looseleaf print subscribers receive supplements. The online edition is updated automatically. After 1 year, the online subscription is only available upon renewal. You will be contacted either via phone or e-mail to set up log-in information to access the digital version.
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