Blog
RSS FeedPosted by Michael Wonder on 06 Jul 2024
Four decades of orphan drugs and priorities for the future
6 July 2024 - The Orphan Drug Act was enacted in the United States in 1983 in response to growing awareness ...
Posted by Michael Wonder on 23 Jun 2024
Top FDA official Peter Marks overruled staff, review team to approve Sarepta gene therapy
20 June 2024 - For a third time, Sarepta Therapeutics has convinced a top FDA official to overrule the prevailing ...
Posted by Michael Wonder on 09 Nov 2023
FDA approves first treatment for patients with rare inherited blood clotting disorder
9 November 2023 - Today, the US FDA approved Adzynma, the first recombinant protein product indicated for prophylactic or on demand ...
Posted by Michael Wonder on 06 Sep 2022
NASWSI and Project Orbis - are they essentially the same?
7 September 2022 - We compare and contrast the two initiatives to bring new medicines to the market faster. ...
Posted by Michael Wonder on 27 Jul 2022
MS Health push for nurses to hand out abortion pills
27 July 2022 - Nurses and midwives would prescribe medical abortion pills under a push by the company that imports ...
Posted by Michael Wonder on 17 Oct 2021
FDA needs a competitiveness czar
15 October 2021 - The FDA needs a Deputy Commissioner for Regulatory Competitiveness. ...
Posted by Michael Wonder on 30 Mar 2021
Terminal cancer patients denied new treatments due to slow TGA approval
31 March 2021 - Desperate cancer patients are begging Australia’s drugs regulator to save lives by speeding up approvals and cutting ...
Posted by Michael Wonder on 08 Jan 2021
FDA statement on following the authorised dosing schedules for COVID-19 vaccines
4 January 2021 - Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 disease ...
Posted by Michael Wonder on 03 Nov 2020
Is it time for the FDA to be independent?
3 November 2020 - Public health experts and lay observers alike have expressed concerns that, under political pressure, the FDA ...
Posted by Michael Wonder on 26 Feb 2019
'Wacky' drug price system keeps costs high for patients paying for prescriptions, FDA chief says
26 February 2019 - "The sick people are helping to subsidise the healthy people. That's not how insurance is supposed to ...
Posted by Michael Wonder on 15 Mar 2018
Product withdrawn after overseas reports of inflammatory brain disorders
15 March 2018 - Consumers and health professionals are advised that Biogen Australia, in consultation with the TGA, will withdraw ...
Posted by Michael Wonder on 20 Nov 2017
EMA to relocate to Amsterdam, the Netherlands
20 November 2017 - Agency to begin working immediately with Dutch government to ensure successful move by end of March ...
Posted by Michael Wonder on 20 Oct 2017
MHRA chief floats faster reviews, closer ties to NICE
19 October 2017 - The head of the United Kingdom’s regulatory agency has sketched out some of the ways it ...
Posted by Michael Wonder on 11 Jul 2017
FDA speeding generic drug approvals: not just lip service
10 July 2017 - May and June 2017 have seen the most generic drug approvals since the US FDA began ...
Posted by Michael Wonder on 19 Jul 2016
Agenda for July 2016 CHMP meeting
19 July 2016 - The agenda for the 18-21 July 2016 CHMP meeting is now available. ...