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RSS FeedPosted by Michael Wonder on 26 Aug 2020
FDA chief apologises for overstating plasma effect on virus
26 August 2020 - Food and Drug Administration Commissioner Stephen Hahn is apologising for overstating the life-saving benefits of using convalescent ...
Posted by Michael Wonder on 25 Aug 2020
As COVID-19 pressures mount, political newcomer Stephen Hahn struggles to protect an FDA under siege
24 August 2020 - Stephen Hahn, a political novice who moved here in December to take over the FDA, has ...
Posted by Michael Wonder on 24 Aug 2020
Trump considers fast-tracking UK COVID-19 vaccine before US election
24 August 2020 - Move comes as FDA gives emergency authorisation for use of plasma from recovered patients. ...
Posted by Michael Wonder on 24 Aug 2020
FDA's convalescent plasma EUA requires all donor blood units be tested only with Ortho's COVID-19 IgG antibody test
24 August 2020 - In its August 23 Emergency Use Authorisation for COVID-19 convalescent plasma for the treatment of hospitalised ...
Posted by Michael Wonder on 23 Aug 2020
FDA issues emergency use authorisation for convalescent plasma as potential promising COVID–19 treatment, another achievement in Administration’s fight against pandemic
23 August 2020 - Today, the U.S. FDA issued an emergency use authorisation for investigational convalescent plasma for the treatment ...
Posted by Michael Wonder on 18 Aug 2020
The FDA response to COVID-19 at six months: regulatory innovation in the face of a pandemic
18 August 2020 - The COVID-19 pandemic has significantly impacted American society, with more than 160,000 deaths and 5 million cases ...
Posted by Michael Wonder on 18 Aug 2020
FDA initiatives to accelerate the development of COVID-19 therapeutics
18 August 2020 - More than 750,000 deaths have occurred worldwide as a result of the novel coronavirus as of ...
Posted by Michael Wonder on 17 Aug 2020
Clinical trials of coronavirus drugs are taking longer than expected
14 August 2020 - Antibody trials sponsored by Regeneron and Eli Lilly are off to a slow start because of a ...
Posted by Michael Wonder on 15 Aug 2020
Valuing innovative drugs based on their cost of manufacturing will prolong the COVID-19 pandemic
14 August 2020 - The value of innovative medicines has absolutely nothing to do with its cost of production. Yet, ...
Posted by Michael Wonder on 12 Aug 2020
US hoses down Russian vaccine, says it will have millions of doses ready year's end
12 August 2020 - US Health Secretary Alex Azar has criticised a COVID-19 vaccine being promoted by Russian President Vladimir ...
Posted by Michael Wonder on 12 Aug 2020
Moderna announces supply agreement with U.S. Government for initial 100 million doses of mRNA vaccine against COVID-19 (mRNA-1273)
11 August 2020 - New U.S. government award up to $1.525 billion for 100 million doses. ...
Posted by Michael Wonder on 11 Aug 2020
FDA head pledges 'we will not cut corners' on coronavirus vaccine
10 August 2020 - The head of the FDA pledged Monday that the U.S. "will not cut corners" in its ...
Posted by Michael Wonder on 10 Aug 2020
Stephen Hahn MD, FDA chief, is caught between scientists and the President
10 August 2020 - Many medical experts - including members of his own staff - worry about whether Dr Hahn ...
Posted by Michael Wonder on 08 Aug 2020
Hard questions as scientists and governments seek COVID-19 vaccines
8 August 2020 - They must work out how much to invest, and how best to distribute the goods. ...
Posted by Michael Wonder on 07 Aug 2020
Unwavering regulatory safeguards for COVID-19 vaccines
7 August 2020 - The coronavirus disease 2019 (COVID-19) pandemic has disrupted normal life and had significant consequences for human health, ...