DDMAC said the first of several piecemeal guidances on social media can be expected during the first quarter of 2011. The first guidance to be issued will deal with one of the following topics, per DDMAC: Responding to unsolicited requests; Fulfilling regulatory requirements when using tools associated with space limitations; Fulfilling post-marketing submission requirements; On-line communications for which manufacturers, packers, or distributors are accountable; Use of links on the Internet; and correcting misinformation. In an email sent via CDER spokesperson Karen Mahoney, DDMAC said its goal is to address "at least one of these topics during the first quarter of 2011," but refused to comment further about "exactly when any draft guidance will be issued, or any specific order in which the topics will be addressed." DDMAC said the public "will be notified officially when any guidance is issued via Federal Register announcements.
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