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Visit the PLI Brand Store here: amazon.com/pli. As the laws change, so do our publications.  Register to receive updates to this publication at PLI.edu/myupdates.

The Eleventh Edition has been extensively updated with significant developments across key areas of pharmaceutical regulation, including a new chapter on the FDA’s shift towards greater transparency and its impact on product liability exposure, updated insights on evolving evidence standards for drug approvals, and the latest best practices for navigating FDA inspections and remote regulatory assessments. It also reflects current rules and enforcement trends surrounding pharmaceutical advertising and promotional activity, provides and overview of the modern enforcement landscape for off-label promotion, and offers fresh analysis of major legal developments affecting False Claims Act exposure for manufacturers, including recent interpretations that may influence damages and qui tam actions.

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