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RSS FeedPosted by Michael Wonder on 13 Aug 2021
Congress should fix FDA’s accelerated approval program for the next 30 years
12 August 2021 - The FDA's approval of the Alzheimer’s drug Aduhelm has sparked a broader debate on the merits ...
Posted by Michael Wonder on 12 Aug 2021
Ellis Unger, an outspoken FDA veteran, retires
12 August 2021 - A top FDA official known for speaking out against controversial drug approval decisions, Ellis Unger, retired ...
Posted by Michael Wonder on 12 Aug 2021
FDA to authorise third vaccine dose for people with weak immune systems
11 August 2021 - The decision to expand the emergency use of both the Pfizer-BioNTech and Moderna vaccines is meant to ...
Posted by Michael Wonder on 11 Aug 2021
‘We don’t unlearn’: what the pandemic has taught regulators about real world data
11 August 2021 - During the pandemic, regulatory agencies deployed emergency measures left and right to speed care to patients. ...
Posted by Michael Wonder on 11 Aug 2021
Pressure builds for full FDA approval of vaccines
11 August 2021 - Pressure is building for the FDA to fully approve the COVID-19 vaccine, a step that could ...
Posted by Michael Wonder on 10 Aug 2021
After court defeat, FDA shifts to regulating some drugs as devices
9 August 2021 - The US FDA is informing stakeholders and the public that it will soon begin implementing a ...
Posted by Michael Wonder on 09 Aug 2021
Ophthalmologist group wants U.S. Government to push back against Avastin biosimilars
10 August 2021 - The American Academy of Ophthalmology says biosimilar alternatives to Avastin have never been tested in the ...
Posted by Michael Wonder on 08 Aug 2021
Biden yet to nominate new FDA chief even as delta surges
8 August 2021 - President Biden has yet to nominate a permanent head of the FDA at a time when ...
Posted by Michael Wonder on 04 Aug 2021
Federal watchdog will review the controversial FDA approval of Biogen’s Alzheimer’s drug
4 August 2021 - The federal watchdog at the Department of Health and Human Services will review the process used ...
Posted by Michael Wonder on 04 Aug 2021
Collecting patient reported outcomes in cancer clinical trials
3 August 2021 - To help patients with cancer learn more about how treatment may affect their quality of life, the ...
Posted by Michael Wonder on 04 Aug 2021
FDA regulation and approval of medical devices: 1976-2020
3 August 2021 - US law generally requires testing of high-risk medical devices prior to approval, as well as pre-market evaluation ...
Posted by Michael Wonder on 04 Aug 2021
Regulating digital health apps needs user-centered reform
3 August 2021 - When people seek health information, they expect what they get to be reliable and accurate. ...
Posted by Michael Wonder on 01 Aug 2021
FDA under pressure to grant full approval to COVID-19 vaccines
1 August 2021 - Some schools, hospitals and employers are hesitant to mandate vaccines while shots are still only authorized for ...
Posted by Michael Wonder on 31 Jul 2021
FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway
30 July 2021 - Criticisms of the US FDA’s accelerated approval process have resurfaced after the recent approval of aducanumab ...
Posted by Michael Wonder on 29 Jul 2021
Congress presses the FDA to move faster on ALS drugs
29 July 2021 - Lawmakers pressed a top FDA official Thursday for answers on why the agency has balked at approving ...