NIH, CDC Distributing OTC COVID-19 Tests In US Study On Reducing Community Transmission
Source : 'HBW Insight'
A COVID-19 test recently cleared for OTC sales in the US will do more than expand consumer access to tests for infections. The National Institutes of Health is paying for 2m...
Coronavirus Notebook: EMA Says ‘Wait And See’ On CureVac Data, EU Ministers Want Voluntary Approach To Sharing IP
Source : 'The Pink Sheet'
It is too early to say whether the 47% efficacy shown in interim results of the Phase IIb/III HERALD study of CureVac NV’s COVID-19 vaccine candidate will be...
US COVID-19 Claim Warnings Continue; Hi-Tech’s Problems Extend To Undeclared Allergens
Source : 'HBW Insight'
US regulatory agencies’ problems with businesses falsely promoting consumer health products as COVID-19 cures haven’t ended, and neither have their problems with dietary supplement firm Hi-Tech Pharmaceuticals Inc., which is...
US FDA Recommendations On Developing Serial COVID-19 Tests Could Accelerate OTC Approval
Source : 'HBW Insight'
The US Food and Drug Administration has made available a development template with recommendations to streamline emergency use authorizations of screening tests for serial COVID-19 testing, which developers can consider...
Gottlieb: No ‘Plan B’ If Woodcock Isn’t Nominated As US FDA Commissioner
Source : 'HBW Insight'
Former commissioner Scott Gottlieb doesn’t see a “plan B” for US Food and Drug Administration leadership beyond Janet Woodcock being moved from acting to permanent commissioner.
Gottlieb also expects that enforcing...