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RSS FeedPosted 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 23 Mar 2021
Indian cancer drug manufacturer to pay $50 million for concealing and destroying records in advance of FDA inspection
23 March 2021 - Indian drug manufacturer Fresenius Kabi Oncology was sentenced to pay $50 million in fines and forfeiture ...
Posted by Michael Wonder on 19 Mar 2021
Too fast or too slow: is the FDA moving at the right speed?
19 March 2021 - Regardless of President Joe Biden’s choice for the next commissioner of the FDA, the Senate Health, Education, ...
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 17 Mar 2021
Leveraging real world evidence in regulatory submissions of medical devices
16 March 2021 - Among the many ways that the U.S. FDA protects and promotes the public health is by ensuring ...
Posted by Michael Wonder on 09 Mar 2021
Biden’s silence on an FDA nominee underscores how tough it is to fill that job
9 March 2021 - Nearly everyone here expected President Biden to move with record speed to nominate someone to lead ...
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 04 Mar 2021
FDA releases a new plan to bring its data skills up to speed
4 March 2021 - When Ram Iyer started his new job at the Food and Drug Administration in 2020, he ...
Posted by Michael Wonder on 02 Mar 2021
Drug industry pushes FDA to solve growing inspection backlog
2 March 2021 - Inspections are a vital tool to ensure the safety of new drugs as well as medicines already ...
Posted by Michael Wonder on 25 Feb 2021
Three steps can help companies speed FDA approval of new drugs
24 February 2021 - Drug developers see FDA approval as a difficult uphill climb, requiring large investments of resources and ...
Posted by Michael Wonder on 23 Feb 2021
FDA to allow Pfizer-BioNTech vaccine to be stored at higher temperatures
24 February 2021 - The U.S. FDA plans to approve Pfizer Inc and BioNTech SE’s request to store their COVID-19 ...
Posted by Michael Wonder on 22 Feb 2021
Voluntary withdrawal of Imfinzi indication in advanced bladder cancer in the US
22 February 2021 - AstraZeneca today announced the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for previously treated ...
Posted by Michael Wonder on 20 Feb 2021
Who will be the next FDA chief?
20 February 2021 - Two leading contenders generate wider debate about the leadership needed to restore morale and scientific integrity to ...
Posted by Michael Wonder on 17 Feb 2021
COVID-19 vaccine approval process: does it take too long?
15 February 2021 - Here are answers to some questions about the FDA review panels. ...
Posted by Michael Wonder on 17 Feb 2021
Reflections on a record year for novel device innovation despite COVID-19 challenges
16 February 2021 - As we look ahead this year, it is important to pause and reflect on the important milestones ...