APHL
FDA Draft Guidances Detail Plans for Enforcement Discretion During Public Health Emergencies
The guidances, which are open for comment through July 5, lay out agency thinking on the regulation of lab-developed tests in emergency situations following its May 6 final rule.
Lack of Standardization Across MDx Infectious Disease Tests Could Undermine Pandemic Preparedness
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Poor cross-compatibility may make it difficult to substitute components of automated sample processing and testing workflows in the case of shortages.
White House COVID Dx Goals Potentially Feasible but More Funding, Coordination Needed, Experts Say
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The timelines the administration set this fall for ramping testing in the event of a health emergency are potentially doable but largely aspirational at the moment.
Backed by almost $9 million in funding from NIH, the organization is working to address what has largely been a gap in testing data throughout the pandemic.
CDC Grants Could Indicate Shift Toward More Federal Funds for Public Health Lab Construction
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The agency announced last month that it provided $175 million to seven states and localities to either build, expand, or renovate public health laboratory space.