Blog
RSS FeedPosted by Michael Wonder on 16 Jan 2024
Human medicines: highlights of 2023
16 January 2024 - In 2023, EMA recommended 77 medicines for marketing authorisation. ...
Posted by Michael Wonder on 21 Nov 2023
FDA faces reckoning over short-cut drug approvals
21 November 2023 - Most people probably assume that all prescription drugs on the US market have been proven effective in ...
Posted by Michael Wonder on 31 Jan 2023
FDA may not always require post-approval trials to be enrolled before accelerated approvals
30 January 2023 - A FDa official on Monday gave more clues for how the agency plans to wield new authority ...
Posted by Michael Wonder on 25 Jan 2023
The 4 biggest questions about the FDA’s forthcoming changes to accelerated approvals
25 January 2023 - Congress just boosted the FDA’s authority over the post-market clinical trials that are a condition of ...
Posted by Michael Wonder on 18 Jan 2023
FDA’s breakthrough program: faster drug OKs without sacrificing safety
18 January 2023 - A FDA program markedly cut the time and cost of bringing to market new drugs, without ...
Posted by Michael Wonder on 11 Jan 2023
Prescription drug policy, 2022 and 2023: the year in review and the year ahead
9 January 2023 - This past year featured many significant developments in the prescription drug policy area, most notably the passage ...
Posted by Michael Wonder on 21 Nov 2022
FDA cancer chief wants quicker ways to pull failed drugs
17 November 2022 - Makena highlights need to make system more nimble. ...
Posted by Michael Wonder on 15 Oct 2022
Gottlieb, McClellan push for FDA regulatory reforms
14 October 2022 - The decision by law makers to drop regulatory reforms of dietary supplements, cosmetics and diagnostic tests from ...
Posted by Michael Wonder on 27 Sep 2022
COVID-19 vaccine procurement review says rapid access to vaccines and treatments key to on-going protection of Australians
27 September 2022 - Medicines Australia welcomes the independent review of Australia’s COVID-19 vaccine and treatment procurements by Professor Jane ...
Posted by Michael Wonder on 27 Sep 2022
Halton review into vaccine and treatment procurement
27 September 2022 - Professor Jane Halton AO has handed to Government her independent review of Australia’s COVID-19 vaccine and treatment ...
Posted by Michael Wonder on 21 Sep 2022
The on- and off-ramps of oncology accelerated approval
21 September 2022 - To address ongoing concerns about the implementation of the FDA’s accelerated approval pathway in oncology, a ...
Posted by Michael Wonder on 17 Aug 2022
Accelerated approval of cancer drugs: no economic reward for drug makers that conduct confirmatory trials
17 August 2022 - The FDA uses expedited approval of drugs to speed the development and assessment of drugs that address ...
Posted by Michael Wonder on 30 Jun 2022
Review into COVID-19 vaccine and treatment purchases
30 June 2022 - The Australian Government is undertaking an independent review of Australia’s vaccine and treatment procurements, led by former ...
Posted by Michael Wonder on 23 Jun 2022
Expediency versus efficacy: re-examining the FDA’s accelerated drug approval process
23 June 2022 - It was precisely 30 years ago, in 1992, that the FDA established the accelerated approval program ...
Posted by Michael Wonder on 29 May 2022
Accelerated approval: unfulfilled promises for FDA’s expedited review program
27 May 2022 - As practicing physicians, approval by the U.S. FDA reassures us that the treatments we prescribe our patients ...