PLI recently published the 2018 edition of Pharmaceutical Compliance and Enforcement Answer Book, which provides a comprehensive overview of the complex regulatory issues faced by the different participants in the pharmaceutical industry.
This resource gives clear, expert answers to questions on topics such as:
- 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.
This new answer book is available on PLI PLUS, our research database. If you’d like to order a print copy, please email libraryrelations@pli.edu or call 877.900.5291.
