nick-otto-articles
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CMS Issues Phase 2 Sunshine Reporting Instructions, Deadlines
5/29/2014
The Centers for Medicare & Medicaid Services posted instructions on completing the second phase of its 2014 reporting process under the Physician Payment Sunshine Act, providing relevant dates, instructions and other information for industry.
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New FDA Guidance Seeks To Smooth Transfers Of Clinical Study Oversight
5/28/2014
Institutional review boards (IRBs) assuming clinical trial oversight from another IRB should provide sponsors an opportunity to address any concerns the receiving IRB has with the study before termination or suspension, according to finalized draft guidance released by the FDA on Friday.
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FDA Pledges Funding For Clinical Trials Improvement Initiative
5/27/2014
The FDA says it will infuse as much as $37.5 million to aid the Clinical Trials Transformation Initiative (CTTI) in its mission to enhance the efficiency and quality of clinical trials.
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