Publisher's Synopsis
Pharmaceutical Compliance and Enforcement Answer Book provides a comprehensive overview of the regulatory issues faced by the different participants in the pharmaceutical industry. In an easy Q&A format, this resource discusses: - The FDA's authority and potential actions to regulate prescription drugs and biologics both before and after approval by the agency- A facility's rights and compliance obligations during an inspection by the agency- How to best evaluate a company's potential of being in violation and what to do to mitigate those risks- What advertising and promotion of prescription drugs is permitted- How product liability issues overlap with FDA enforcement initiatives- When criminal prosecution is used as part of the regulatory enforcement effort Filled with practical suggestions, Pharmaceutical Compliance and Enforcement Answer Book provides attorneys and compliance officers with a roadmap to effective compliance with FDA pharmaceutical regulations.
