Blog
RSS FeedPosted by Michael Wonder on 14 Dec 2020
Public posting of a comprehensive surrogate endpoint table for CDER and CBER regulated products
11 December 2020 - The public posting of a surrogate endpoint table for both reasonably likely and validated surrogate outcomes was ...
Posted by Michael Wonder on 10 Dec 2020
Federal watchdog urged to investigate the FDA’s handling of Biogen Alzheimer’s drug
9 December 2020 - A federal watchdog is being asked to investigate the FDA for an “inappropriate collaboration” with Biogen ...
Posted by Michael Wonder on 10 Dec 2020
FDA holds advisory committee meeting to discuss authorisation of COVID-19 vaccine candidate as part of Agency’s review of safety and effectiveness data
10 December 2020 - The following is attributed to FDA Commissioner Stephen M. Hahn. ...
Posted by Michael Wonder on 08 Dec 2020
Pfizer's vaccine offers COVID-19 protection after first dose, FDA says
9 December 2020 - Pfizer has cleared the next hurdle in the race to get its COVID-19 vaccine approved for ...
Posted by Michael Wonder on 08 Dec 2020
CDER focuses on novel drug development tools to help speed creation of new therapies
7 December 2020 - There are many novel drug development tools that incorporate the latest advances in science and technology but ...
Posted by Michael Wonder on 06 Dec 2020
HHS’s Alex Azar says Pfizer vaccine could receive green light within days
6 December 2020 - The top U.S. health official said the federal government could authorise Pfizer’s COVID-19 vaccine within days ...
Posted by Michael Wonder on 03 Dec 2020
The dawn of digital medicine
2 December 2020 - The pandemic is ushering in the next trillion-dollar industry. ...
Posted by Michael Wonder on 03 Dec 2020
Pushed to rush, FDA head says feds will get vaccine 'right'
2 December 2020 - The head of the agency responsible for authorising COVID-19 vaccines says it will take the time needed ...
Posted by Michael Wonder on 30 Nov 2020
Deploying big data to determine how well vaccines work
29 November 2020 - As the initial rollout starts, it’s time to start planning a registry to monitor health outcomes. ...
Posted by Michael Wonder on 24 Nov 2020
Success for a third—and perhaps most important—COVID-19 vaccine
23 November 2020 - The AstraZeneca-Oxford jab is likely to be widely used around the world. ...
Posted by Michael Wonder on 21 Nov 2020
Pfizer and BioNTech to submit emergency use authorisation request today to the U.S. FDA for COVID-19 vaccine
20 November 2020 - In addition to today’s submission to the FDA, the companies have already initiated rolling submissions across the ...
Posted by Michael Wonder on 18 Nov 2020
Does remdesivir actually work against COVID-19?
17 November 2020 - The evidence shows only that the drug might be effective. That once wasn’t enough for FDA approval. ...
Posted by Michael Wonder on 17 Nov 2020
FDA’s ongoing commitment to transparency for COVID-19 EUAs
17 November 2020 - Emergency use authorisations, or EUAs, are an important tool in our country’s fight against COVID-19 and other ...
Posted by Michael Wonder on 16 Nov 2020
HHS Secretary Azar says the FDA will move ‘as quickly as possible’ to clear Moderna and Pfizer’s COVID-19 vaccines
16 November 2020 - There should be enough vaccine doses made by Pfizer and Moderna to inoculate roughly 20 million before ...
Posted by Michael Wonder on 12 Nov 2020
The challenges ahead with monoclonal antibodies: from authorisation to access
11 November 2020 - When President Trump received an infusion of a monoclonal antibody cocktail (REGN-COV2, Regeneron) on October 2, ...