MDUMFA II Discussions May Touch On Need For FDA Guidance, Transparency
This article was originally published in The Gray Sheet
Executive Summary
Industry is not satisfied with FDA's current rate of issuing guidances, according to Anthony Blank, Boston Scientific VP-cardiovascular regulatory affairs
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House To Probe Presidential Oversight Of Agency Guidances, Regs
Two House subcommittees are planning a joint hearing on amended 1Executive Order 12866, which institutionalizes the review of federal agency regulations and guidance documents by presidential appointees
House To Probe Presidential Oversight Of Agency Guidances, Regs
Two House subcommittees are planning a joint hearing on amended 1Executive Order 12866, which institutionalizes the review of federal agency regulations and guidance documents by presidential appointees
MDMA Annual Meeting In Brief
CED is coming soon: Revised draft guidance on CMS' coverage-with-evidence development policy is expected out within "weeks," agency Administrator Mark McClellan said June 15 at the Medical Device Manufacturers Association annual meeting in Washington, D.C. Despite rumors following the first draft guidance that CED was dead in the water due to concerns about basing coverage on patient consent, the new version will address the issue (1"The Gray Sheet" May 8, 2006, p. 7). "We want to get this right," McClellan said...