When to Request Clarification from Regulators
When to Request Clarification from Regulators Knowing When to Seek Clarification from Regulatory Authorities Introduction: The High Stakes of Misinterpreting Regulatory Queries During the lifecycle of drug or device development, regulatory agencies such as the U.S. FDA, European Medicines Agency (EMA), and Japan’s PMDA often send communications that include questions, comments, or observations. These queries…