Pharmaceutical Compliance and Enforcement Answer Book

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