Industry Waits for Some Signal That FDA Will Rethink Its Proposed Approach to Unsolicited Requests
As previously reported, while a key focus of the draft is clearly on public requests arising out of Web 2.0 social media forums, the manner in which the draft guidance limits a firm's ability to substantively respond to public requests raises serious concerns in a both electronic and non-electronic media forums, including first amendment free speech concerns (See “FDA on Free Speech and How to Respond to Tweets” – MDDI: Medical Device & Diagnostic Industry, February 6, 2012). In light of the widespread concerns, it may be some time before stakeholders have an indication from FDA as to how the agency will proceed.
As reported here, earlier this month the U.S. Drug Enforcement Administration (DEA) issued a decision declining to transfer marijuana out of Schedule I. As marijuana remains a Schedule I...07 September 2016