Life Sciences Regulatory Enforcement Resource Kit

This resource kit provides quick access to essential content and tools for advising your life sciences clients that are subject to oversight and enforcement actions by very active federal and state administrative agencies, including the FDA.

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Related Content

• FDA Warning Letters Tracker
  Monitor warning letters issued by the FDA in response to its determination that a manufacturer has violated, or potentially violated, applicable requirements of the FDCA, FDA regulations, or agency guidance. 

• FDA Form 483 Inspection Observations and Responses
  Understand how to respond to Form 483 inspectional observations and learn key points to discuss with a pharmaceutical or medical device company client after its facility has been inspected by the FDA.

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