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OverviewPLI's Pharmaceutical Compliance and Enforcement Answer Book 2016 provides a comprehensive overview of the regulatory issues faced by the different participants in the pharmaceutical industry. In an easy Q&A format, Pharmaceutical Compliance and Enforcement Answer Book 2016 describes: - 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 2016 provides the attorney and his or her clients with a roadmap to effective compliance with FDA pharmaceutical regulations. Full Product DetailsAuthor: Howard L. DorfmanPublisher: Practising Law Institute Imprint: Practising Law Institute Dimensions: Width: 15.20cm , Height: 3.00cm , Length: 23.20cm Weight: 0.817kg ISBN: 9781402426131ISBN 10: 1402426135 Pages: 586 Publication Date: 07 June 2016 Audience: General/trade , General Format: Paperback Publisher's Status: Active Availability: In stock  We have confirmation that this item is in stock with the supplier. It will be ordered in for you and dispatched immediately. Table of ContentsReviewsAuthor InformationTab Content 6Author Website:Countries AvailableAll regions |
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