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Photo source: iStock/AlexLMX FDA s Center for Devices and Radiological Health has posted a list of the guidance documents it plans to publish in fiscal year 2016 as either final or draft guidances. It has also posted a list of previously issued final guidances for which the center is interested in receiving external feedback on whether they should be revised or withdrawn. Several of these guidances could be of interest to medical device packaging professionals. CDRH asks that comments on any of these guidance documents be submitted to docket FDA-2012-N-1021. FDA has divided the potential guidance documents that could be published as either final or draft into an A list and a B list. The A list is a list of prioritized device guidance documents that the Agency intends to publish within 12 months of the date this list is published each fiscal year, whereas the B list is a list of device guidance documents that the Agency intends to publish as resources permit e ....
Dave Donelson, elected in District 1. Randy Helms, elected in District 2. Springs Opportunity Fund, a so-called 527 committee, named for the IRS code under which such groups are organized, spent $128,000 promoting candidacies of Dave Donelson in District 1, Randy Helms in District 2 and Mary Elizabeth Fabian in District 5. Itâs called a âdark moneyâ group because the rules allow them to shield the source of campaign money from the public. All three candidates supported by Springs Opportunity Fund are registered Republicans. Though Council races are nonpartisan, it appears the outside committee carried out a GOP mission, given who was pulling the strings. More on that later. ....