Posts tagged informed consent information sheets.
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As reported previously in this blog and in an EBG Client Alert, FDA has recently reopened the comment periods for three draft guidance documents released this year: two on social media promotion (open until October 29) and one on informed consent information sheets (open until October 27). FDA does not often reopen the door to comment after the required notice-and-comment period has closed, and the fact that FDA has chosen to do so for these draft guidances is significant. In all three cases, FDA received communications from stakeholders requesting additional time to digest the ...
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