Sunshine Act Deadline Is Still Cloudy As Registration Not Yet Available
This article was originally published in The Pink Sheet Daily
Physician payment data is coming due, but stakeholders continue to press CMS for clarity on the deadline for the first set of information since conflicting instructions are on the agency’s website.
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Drug makers get three more months to comply than the proposed rule offered; firms must send the data by March 31, 2014, to CMS, which plans to make the information available on a public website by Sept. 30, 2014.
FDA indicates it expects sponsors and other government agencies to come up with ways to fulfill its request for placebo-controlled studies post-emergency use authorization of COVID-19 vaccines, but neither it nor vaccines advisory committee see a clear way to do this.
Ahead of the vaccine advisory committee, requests to FDA range from public health groups opposing emergency use authorizations to industry seeking labeling guidance on EUA products.