Blog
RSS FeedPosted by Michael Wonder on 17 Jun 2021
Furore rages over FDA approval of controversial Alzheimer’s drug
17 June 2021 - Critics attack the agency’s action as reckless, but defenders say patients will benefit. ...
Posted by Michael Wonder on 17 Jun 2021
The FDA is in desperate need of some soul-searching
17 June 2021 - Ordinarily, the approval of a new drug for a dreaded disease affecting millions of Americans would be ...
Posted by Michael Wonder on 17 Jun 2021
COVID-19 vaccine weekly safety report (17 June 2021)
17 June 2021 - Twelve additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...
Posted by Michael Wonder on 16 Jun 2021
German law makers seek to ease reimbursement for advanced therapies
15 June 2021 - Advanced therapy trade group The Alliance for Regenerative Medicine has highlighted the passage of a new ...
Posted by Michael Wonder on 16 Jun 2021
HHS proposes rescinding Trump era insulin, epinephrine rule
15 June 2021 - The HHS is proposing to rescind a Trump administration drug rule requiring community health centers to ...
Posted by Michael Wonder on 16 Jun 2021
‘A litany of flaws’: advocacy group urges HHS to boot FDA officials over Alzheimer’s drug approval
16 June 2021 - Reacting to the controversial approval of the Biogen Alzheimer’s drug, a leading advocacy group is urging ...
Posted by Michael Wonder on 15 Jun 2021
6 ways the FDA’s approval of Aduhelm does more harm than good
15 June 2021 - Like many people, I was shocked when the FDA ignored the advice of its neurological drugs ...
Posted by Michael Wonder on 14 Jun 2021
Vaxzevria: EMA advises against use in people with history of capillary leak syndrome
11 June 2021 - EMA’s safety committee (PRAC) has concluded that people who have previously had capillary leak syndrome must not ...
Posted by Michael Wonder on 14 Jun 2021
The FDA still lacks a permanent chief, despite pressing, weighty problems
12 June 2021 - With the pandemic easing, the federal agency’s long-term agenda for drug approvals or new issues is languishing ...
Posted by Michael Wonder on 11 Jun 2021
Third member of prestigious FDA panel resigns over approval of Biogen's Alzheimer's drug
10 June 2021 - A third member of a key FDA advisory panel has resigned over the agency's controversial decision to ...
Posted by Michael Wonder on 10 Jun 2021
America’s approval of an Alzheimer’s drug is premature
12 June 2021 - It may offer false hope and divert resources from more promising therapies. ...
Posted by Michael Wonder on 10 Jun 2021
COVID-19 vaccine weekly safety report (10 June 2021)
10 June 2021 - Seven additional cases of blood clots with low blood platelets have been assessed as thrombosis with ...
Posted by Michael Wonder on 10 Jun 2021
Two members of U.S. FDA advisory panel resign over Alzheimer's drug approval
9 June 2021 - Two members of a panel of outside advisors to the U.S. FDA have resigned in protest ...
Posted by Michael Wonder on 07 Jun 2021
Proposed refinements to the regulation of personalised medical devices
7 June 2021 - Regulatory changes introducing a new framework for the regulation of personalised medical devices commenced on 25 ...
Posted by Michael Wonder on 07 Jun 2021
Innovative regenerative medicine therapies – patient safety comes first
3 June 2021 - The U.S. FDA continues to facilitate the development and availability of innovative medical products, such as regenerative ...