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RSS FeedPosted by Michael Wonder on 16 Feb 2021
After a controversial Alzheimer’s drug review, FDA’s Woodcock rejects proposal to ‘firewall’ agency and drug companies
16 February 2021 - In response to criticism, a top FDA official maintained that creating a firewall between agency staff ...
Posted by Michael Wonder on 16 Feb 2021
The US regulatory system and COVID-19 vaccines: the importance of a strong and capable FDA
15 February 2021 - For many in public health and medicine, the coronavirus disease 2019 (COVID-19) pandemic in the US has ...
Posted by Michael Wonder on 11 Feb 2021
FDA’s generic drug program in 2020 helped ensure availability of high quality, affordable drugs amid COVID-19
11 February 2021 - Generic drugs play a vital role in facilitating access to lifesaving medicines for Americans and remain a ...
Posted by Michael Wonder on 09 Feb 2021
Woodcock vs. Sharfstein: a head to head comparison of Biden’s top choices for FDA commissioner
9 February 2021 - President Biden will soon have to nominate someone to helm the FDA. ...
Posted by Michael Wonder on 28 Jan 2021
Advocacy groups urge Biden administration not to tap Woodcock as FDA commissioner
27 January 2021 - As the Biden White House attempts to fashion its health policies, a coalition of consumer and ...
Posted by Michael Wonder on 24 Jan 2021
The stakes for choosing the right FDA commissioner couldn’t be higher
24 January 2021 - An independent, credible, science led Food and Drug Administration has long been vital to America’s public, ...
Posted by Michael Wonder on 21 Jan 2021
Biden appoints veteran Woodcock as interim FDA commissioner
21 January 2021 - Agency veteran Dr Janet Woodcock is the new interim FDA commissioner appointed by president Joe Biden ...
Posted by Michael Wonder on 18 Jan 2021
FDA sped progress for most of 2020's novel drugs
14 January 2021 - Most novel drugs approved by the US FDA in 2020 made their way through the approvals process ...
Posted by Michael Wonder on 14 Jan 2021
FDA veteran Woodcock being considered to lead agency under Biden
14 January 2021 - Joshua Sharfstein, former Obama FDA official, also in running. ...
Posted by Michael Wonder on 14 Jan 2021
FDA releases artificial intelligence/machine learning action plan
12 January 2021 - Today, the U.S. FDA released the agency’s first artificial intelligence/machine learning-based software as a Medical Device Action ...
Posted by Michael Wonder on 14 Jan 2021
Workshop on evaluating RWE from observational studies in regulatory decision-making
12 January 2021 - The FDA and the Duke-Margolis Center for Health Policy will hold a virtual workshop focused on ...
Posted by Michael Wonder on 11 Jan 2021
FDA takes steps to provide clarity on developing new drug products in the age of individualised medicine
4 January 2021 - Advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug ...
Posted by Michael Wonder on 10 Jan 2021
2020: a strong year for new drug therapy approvals – despite many COVID-19 challenges
8 January 2021 - Throughout 2020, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research was challenged ...
Posted by Michael Wonder on 16 Dec 2020
In a petition, Boehringer warns FDA its definition of ‘strength’ threatens biosimilar competition
10 December 2020 - Arguing the FDA is precluding competition for biosimilar manufacturers, Boehringer Ingelheim has petitioned the agency to ...
Posted by Michael Wonder on 15 Dec 2020
AMAG Pharmaceuticals files submission in response to the FDA’s notice of opportunity for a hearing and proposal to withdraw approval of Makena (hydroxyprogesterone caproate injection)
14 December 2020 - AMAG Pharmaceuticals has submitted its response to the FDA’s Notice of Opportunity for a Hearing regarding the ...