Budget Deal Gives Congress A Month To Fund Federal Agencies
This article was originally published in The Tan Sheet
The deal prevents another government shutdown during fiscal 2104 and provides some relief from sequestration of government funds. According to industry analysis, the bill allows FDA full access to company-paid user fees in fiscal 2014 and 2015, rather than having a percentage of the fees sequestered.
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FDA Open To Home COVID-19 Testing With Caveats, OIVD’s Stenzel Says; Grants First Serology Test EUA To BD
The US FDA is open to the idea of home-testing for the COVID-19 virus, but only after making sure the test is completely safe and effective, and available only through a physician’s oversight, said Tim Stenzel, director of the agency’s Office of In Vitro Diagnostics and Radiological Health. Stenzel also heralded the FDA’s first emergency use authorization for a coronavirus serology test, which was granted to diagnostic developer Becton Dickinson.
US Vice President Mike Pence and Medicare administrator Seema Verma want academic and university hospital laboratories to send their de-identified COVID-19 test data results, daily, to the Department of Health and Human Services. Commercial and private labs are exempt from the request, as they already share their coronavirus test results with the government.
The US FDA wants to expand the availability of surgical apparel – including gowns, hoods and examination gloves – for health care professionals to use for the duration of the COVID-19 public health crisis. That means the agency will “not object” to the use of gowns and gloves providing low-to-minimal protection, as long as they do not create an undue risk to patients or users.