Pharmaceutical Law: Regulation of Research, Development and Marketing

Wendy C. Goldstein, Lynn Shapiro Snyder and Robert E. Wanerman have written the following two chapters for the publication entitled Pharmaceutical Law: Regulation of Research, Development and Marketing.

Chapter 5: Federal Regulation of Clinical Research

Chapter 6: Avoiding Fraud and Abuse Penalties and Sanctions

Pharmaceutical Patent Law takes on the complicated task of tracking legal developments within the PTO, FDA, Congress, the courts, the FTC, the Department of Justice, and the WTO; examining how these agencies and organizations interact with each other; and determining how they impact strategies within a practitioner's core area of focus.

This comprehensive treatise is the only reference available with a detailed, practitioner-oriented treatment of pharmaceutical patent law from the perspective of both patent law and the food and drug laws. This publication:

  • Addresses the considerable fraud-and-abuse risks particularly relevent to this submarket of the health care industry
  • Covers off-label marketing — selling a drug for a purpose other than its intended use
  • Explains and discusses the other hot risks areas — including the potential for antitrust, securities law, and other compliance violations

For a more detailed description of this publication and to obtain a copy, please visit BNA's website at