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Unapproved Communication Methods with regulatory agencies refer to any means of interaction or information exchange that deviate from established protocols or guidelines set forth by regulatory bodies. This can include informal conversations, emails, or meetings that occur without proper documentation, review, or adherence to regulatory compliance standards. Such methods can pose significant risks, including the potential for misinformation, lack of transparency, and non-compliance with regulatory requirements. To mitigate these risks, organizations must strictly adhere to approved channels of communication and ensure all interactions are appropriately documented and reviewed to maintain regulatory integrity and transparency.