Blog
RSS FeedPosted by Michael Wonder on 11 Nov 2020
FDA offers guidance to enhance diversity in clinical trials, encourage inclusivity in medical product development
9 November 2020 - To further promote and protect public health, it is important that people who are in clinical trials ...
Posted by Michael Wonder on 03 Nov 2020
Regulatory policy may not stop comparative efficacy trials
4 November 2020 - The way Sarfaraz K. Niazi, looks at it, doing comparative efficacy studies in humans to confirm that ...
Posted by Michael Wonder on 03 Nov 2020
The FDA's cutoff for COVID-19 vaccine effectiveness is 50 percent. What does that mean?
3 November 2020 - Over the summer, the FDA announced that in order for an experimental COVID-19 vaccine to get ...
Posted by Michael Wonder on 01 Nov 2020
The FDA’s Digital Health Center Of Excellence: why it matters and what it means to you
29 October 2020 - Last month, the US FDA launched the Digital Health Center of Excellence, bolstering the shift toward digital ...
Posted by Michael Wonder on 01 Nov 2020
A CDER study of factors that may predict the likelihood of generic drug marketing applications
28 October 2020 - The investigators compiled proprietary data related to abbreviated new drug applications and other internal or public ...
Posted by Michael Wonder on 29 Oct 2020
The FDA will not inspect vaccine production plants
29 October 2020 - Approval of a vaccine by the FDA typically requires inspection of the vaccine’s manufacturing plants. ...
Posted by Michael Wonder on 24 Oct 2020
FDA shows signs of cold feet over emergency authorisation of COVID-19 vaccines
23 October 2020 - There are serious signs the FDA is getting cold feet over the notion of issuing emergency ...
Posted by Michael Wonder on 21 Oct 2020
How the FDA stood up to the President
20 October 2020 - Dr. Stephen Hahn, the F.D.A. commissioner, occupies a fraught position, caught between pressure from the White House ...
Posted by Michael Wonder on 21 Oct 2020
California plans to review coronavirus vaccine independently
19 October 2020 - California is planning to review federally approved coronavirus vaccines independently before distributing it to residents, Governor ...
Posted by Michael Wonder on 20 Oct 2020
Roche CEO warns against high hopes for speedy Covid vaccines
20 October 2020 - Many people’s hopes for a speedy coronavirus vaccine are still too high, Roche Holding AG Chief ...
Posted by Michael Wonder on 19 Oct 2020
All eyes on a hurdle race for a SARS-CoV-2 vaccine
19 October 2020 - Leading COVID-19 vaccine candidates have progressed through laboratory tests at record speed. ...
Posted by Michael Wonder on 15 Oct 2020
Testing requirements are likely slowing biosimilar entries in the US
14 October 2020 - Biosimilars have been slow to enter the US market for complex reasons ranging from the manipulation ...
Posted by Michael Wonder on 12 Oct 2020
Pfizer trying to defuse critics amid push for vaccine before Election Day
10 October 2020 - The company behind President Donald Trump’s last hope for a vaccine by Election Day has quietly ...
Posted by Michael Wonder on 11 Oct 2020
Can Trump really speed approval of COVID treatments?
10 October 2020 - In a five minute video posted to his Twitter account on Wednesday, President Trump stood in ...
Posted by Michael Wonder on 09 Oct 2020
MHRA to join Project Orbis
8 October 2020 - The UK is set to join the US FDA's Project Orbis at the start of next ...