Pharmaceutical and medical device law
Subtitle: regulation of research, development, and marketing
By: by Michael E. Clark, American Bar Association Health Law Section
Contributors: American Bar Association. Health Law Section
Edition: Second edition.
Publisher: Bloomberg BNA
Published: 2015
Place of publication: Arlington, VA
Language: eng
Subjects: Drugs; Medical instruments and apparatus industry; Law and legislation; Pharmacy; Drug development
Notes: Includes index.
Table of contents: title: Statutory and regulatory controls for drug development / James E. Szalados; title: Key federal agencies regulating pharmaceuticals / Tamela J. White, Barnard S. Vallejos; title: Federal regulation of advertising, promotion, and distribution practices / Scott McBride, Krista Barnes, Michael E. Clark; title: Potential liability for drug companies, health care providers and insurers : off-label prescribing and internet advertising / Paul W. Radensky, James M. Woods, Areta Kupchyk; title: Federal regulation of clinical research / Robert Wanerman, Wendy Goldstein, Lynn Shapiro Snyder; title: Avoiding fraud and abuse penalties and sanctions / Robert Wanerman, Wendy Goldstein, Lynn Shapiro Snyder; title: Regulation of privacy under HIPAA and other privacy laws / June M. Sullivan; title: Federal sentencing guidelines and compliance measures / Kathleen M. McDermott; title: The FDA approval process for new drugs / Lil G. Delcampo, Stacy Rummel Bratcher, Bradley I. Kramer; title: State regulatory schemes for pharmaceuticals and related issues / Corey D. Babington, Laura A. Carpenter; title: Antitrust and intellectual law issues for pharmaceutical companies / Michael E. Clark, Carol A. Poindexter; title: Securities law issues and disclosure considerations for pharmaceutical companies / Michael E. Clark.