www.fdanews.com/articles/179735-fda-extends-comment-period-for-public-hearing-on-off-label-communication
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.