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 agencyA facility's rights and compliance obligations during an inspection by the agencyHow to best evaluate a company's potential of being in violation and what to do to mitigate those risksWhat advertising and promotion of prescription drugs is permittedHow product liability issues overlap with FDA enforcement initiativesWhen criminal prosecution is used as part of the regulatory enforcement effortFilled with practical suggestions, Pharmaceutical Compliance and Enforcement Answer Book provides attorneys and compliance officers with a roadmap to effective compliance with FDA pharmaceutical regulations.

In an easy Q&A format, Pharmaceutical Compliance and Enforcement Answer Book 2015 describes: -The FDA's authority and potential actions to regulate prescription drugs and biologics -A facility's rights and compliance obligations -What advertising and promotion of prescription drugs is permitted -How product liability issues overlap with FDA enforcement -When criminal prosecution is used

This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.