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FDA Extends Comment Period for Public Hearing on Off-Label Communication

December 16, 2016

The FDA has extended the comment period for the public hearing on off-label promotion by 90 days to April 10.

The extension is intended to give stakeholders additional time to submit comments, the FDA said, providing no further explanation. A notice of the extension is slated to appear in the Federal Register soon.

The FDA plans to use the responses to develop regulations and policies for off-label communications. Drugmakers have long asked the FDA to revisit agency policies and to loosen agency oversight and clarify boundaries.

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