COVID-19 Assay’s False-Negative Results Culminate In Class I Recall Designation From FDA
Source : Medtech Insight
A recall of the Lyra SARS-CoV-2 Assay (M120) made by Quidel has been designated as high-risk class I by the US Food and Drug Administration.
The FDA said on 7 July...
COVID-19 Vaccines: Declining Antibody Levels, Breakthrough Infections Could Spur Booster Recommendations
Source : 'The Pink Sheet'
Significant declines in antibody levels or concerning numbers of breakthrough infections in vaccinated individuals should spur consideration for booster doses of currently authorized COVID-19 vaccines, members of the Centers for...
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Dr Hamid5yrBooster dose recommendations could be triggered when antibodies decline to a certain level
FDA Pulls EUAs For Non-NIOSH Masks And Decontamination Systems
Source : Medtech Insight
The US Food and Drug Administration has revoked emergency use authorization (EUA) for certain imported respirators for health care workers, and decontamination systems that were allowed due to...
Start Designing Vaccines For The Next Pandemic, Urges NIH Chief
Source : 'The Pink Sheet'
US National Institutes of Health Director Francis Collins is putting out the call for the biopharma industry to start preparing to tackle the pathogens most likely to cause the next...
