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Originally slated to be released this summer, the guidance will detail the formal steps involved in qualifying biomarkers for FDA approval.
An FDA official said that the agency has formalized the "progressive" biomarker qualification process described in the paper and will be releasing a draft guidance detailing the formal steps of the process this July.
The US Food and Drug Administration is to announce stricter standards for emergency authorizations of SARS-CoV-2 vaccines, reports the Washington Post.
The Associated Press reports Johnson & Johnson is starting a late-stage clinical trial of its candidate SARS-CoV-2 vaccine.
Bloomberg reports the budget of Operation Warp Speed is actually $18 billion, higher than the number typically cited.
In Genome Research this week: genomic analysis reveals role of super-spreaders in SARS-CoV-2, epigenetic drivers of cancer, and more.