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Recent Developments in Food and Drug Law provides you with an authoritative, insider's perspective on helping clients navigate and comply with guidance changes in manufacturing and labeling practices. In this volume, you'll find experienced partners from nationwide law firms discussing common FDA violations, including failure to have written procedures and train employees, and outlining the parts of an investigation, including triggers and future avoidance.
These lawyers offer you advice on increasing client focus on manufacturing practices, encouraging pharmaceutical companies to develop take back programs for their jurisdictions, and assisting clients in registering as outsourcing facilities. Covering a range of topics, from understanding the Food Safety Modernization Act to overcoming pharmacy compliance issues, these authors stress the importance of educating your clients on reevaluating food safety plans and divulge best practices for helping clients appropriately label products based on intended use. This book also discusses why your clients should include provisions in manufacturing contracts to ensure that suppliers are liable in the event of compliance failures, and offers advice on developing inspection compliance and response practices.