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RSS FeedPosted by Michael Wonder on 09 Apr 2021
Pfizer requests FDA clearance for vaccine in kids ages 12 to 15
9 April 2021 - The FDA's review process will probably take several weeks, experts say. The move would make Pfizer's vaccine ...
Posted by Michael Wonder on 06 Apr 2021
FDA makes two revisions to Moderna COVID-19 vaccine emergency use authorization to help increase the number of vaccine doses available
1 April 2021 - Today, the U.S. FDA announced two revisions regarding the number of doses per vial available for the ...
Posted by Michael Wonder on 29 Mar 2021
Amazon gets emergency FDA approval for at-home COVID-19 test kit
26 March 2021 - Amazon on Friday received emergency use authorisation from the FDA for an at-home COVID-19 testing kit that ...
Posted by Michael Wonder on 24 Mar 2021
FDA authorises LetsGetChecked’s home collection coronavirus (COVID-19) test for direct to consumer purchase
24 March 2021 - The direct to consumer test is now authorised by the FDA to sell directly to consumers online ...
Posted by Michael Wonder on 24 Mar 2021
DoorDash launches on-demand delivery of COVID-19 PCR test collection kits through partnerships with Vault Health and Everlywell
22 March 2021 - New partnerships make same-day delivery of FDA authorised COVID-19 test collection kits widely available to consumers across ...
Posted by Michael Wonder on 23 Mar 2021
AstraZeneca vaccine trial data questions raised by US drug agency
23 March 2021 - Promising results announced on Monday from AstraZeneca’s American vaccine trials may have relied on an incomplete ...
Posted by Michael Wonder on 20 Mar 2021
FDA authorises first machine learning-based screening device to identify certain biomarkers that may indicate COVID-19 infection
19 March 2021 - Device may be used to identify biomarkers indicative of SARS-CoV-2 infection among certain asymptomatic individuals following a ...
Posted by Michael Wonder on 17 Mar 2021
FDA permits marketing of first SARS-CoV-2 diagnostic test using traditional premarket review process
17 March 2021 - BioFire Respiratory Panel 2.1 is the first COVID-19 diagnostic test granted marketing authorisation using the de novo ...
Posted by Michael Wonder on 17 Mar 2021
U.S. plans to use real world and trial data to determine when vaccines need to be updated
17 March 2021 - U.S. officials plan to use data gathered from people who have already been vaccinated against COVID-19 as ...
Posted by Michael Wonder on 15 Mar 2021
Facebook to label all posts about coronavirus vaccines
15 March 2021 - Facebook, which has been criticised by politicians and researchers for allowing vaccine misinformation to spread on ...
Posted by Michael Wonder on 09 Mar 2021
Pandemic forces FDA to sharply curtail drug company inspections
9 March 2021 - The steep decline in oversight has stalled a number of new drug applications. ...
Posted by Michael Wonder on 08 Mar 2021
Women report worse side effects after a COVID-19 vaccine
8 March 2021 - Men and women tend to respond differently to many kinds of vaccines. That’s probably because of a ...
Posted by Michael Wonder on 01 Mar 2021
FDA allows more flexible storage, transportation conditions for Pfizer-BioNTech COVID-19 vaccine
25 February 2021 - Update Provides Alternative Temperature for Transportation and Temporary Storage for Frozen Vials Before Dilution. ...
Posted by Michael Wonder on 01 Mar 2021
Johnson & Johnson COVID-19 vaccine authorised by U.S. FDA for emergency use - first single shot vaccine in fight against global pandemic
27 February 2021 - Johnson & Johnson today announced that the U.S. FDA has issued emergency use authorisation for its single-dose ...
Posted by Michael Wonder on 27 Feb 2021
FDA issues emergency use authorisation for third COVID-19 vaccine
27 February 2021 - Action advances fight against COVID-19, follows comprehensive evaluation of available safety, effectiveness and manufacturing quality information by ...