Blog
RSS FeedPosted by Michael Wonder on 02 Jul 2024
Standardisation of practice on publication of indications in Swiss Public Assessment Report
1 July 2024 - In order to standardise practice, Swissmedic will in future publish both the proposed and approved indications in ...
Posted by Michael Wonder on 01 Nov 2023
Landmark listing of first three countries as WHO listed regulatory authorities
31 October 2023 - The Health Sciences Authority, Singapore; the Ministry of Food and Drug Safety, Republic of Korea; and ...
Posted by Michael Wonder on 22 Feb 2022
European medicines regulatory network adopts EU common standard for electronic product information
22 February 2022 - The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information on medicines ...
Posted by Michael Wonder on 20 Jul 2021
Streamlining proprietary ingredient categories
20 July 2021 - To help make the medicines application process more efficient, the TGA no longer allocates proprietary ingredient ...
Posted by Michael Wonder on 24 Mar 2021
Biden’s choice and FDA’s loosening standards of evidence
23 March 2021 - The US Food and Drug Administration is widely considered the world’s premier regulator of drugs and devices, ...
Posted by Michael Wonder on 01 Nov 2020
The FDA’s Digital Health Center Of Excellence: why it matters and what it means to you
29 October 2020 - Last month, the US FDA launched the Digital Health Center of Excellence, bolstering the shift toward digital ...
Posted by Michael Wonder on 26 Oct 2020
European Union would apply lower threshold in assessing COVID-19 vaccine
25 October 2020 - The EU’s drug regulator is willing to approve a vaccine even if it were effective in less ...
Posted by Michael Wonder on 30 Sep 2020
The FDA and the importance of trust
30 September 2020 - As SARS-CoV-2 emerged, the global scientific community first studied the virus at the bench, then took what ...
Posted by Michael Wonder on 08 Sep 2020
Biopharma leaders unite to stand with science
8 September 2020 - Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the ...
Posted by Michael Wonder on 11 Aug 2020
FDA head pledges 'we will not cut corners' on coronavirus vaccine
10 August 2020 - The head of the FDA pledged Monday that the U.S. "will not cut corners" in its ...
Posted by Michael Wonder on 21 Jul 2020
Pharma execs say FDA will not lower standards for coronavirus vaccine
21 July 2020 - Drug company executives sought to reassure House Democrats that the federal government is not lowering its ...
Posted by Michael Wonder on 16 Apr 2020
Bayer's chloroquine donation to U.S. raises concern about FDA standards in pandemic
16 April 2020 - On March 21, two days after President Donald Trump first touted chloroquine drugs as a “game ...
Posted by Michael Wonder on 13 May 2019
Two words to help Ned Sharpless revolutionise clinical trials: data standards
13 May 2019 - In the classic 1967 film “The Graduate,” young Benjamin Braddock was given one word of advice ...
Posted by Michael Wonder on 23 Jan 2019
Physicians’ perspectives on FDA approval standards and off-label drug marketing
22 January 2019 - Recently, two fundamental aspects of the US FDA’s pharmaceutical market oversight have become controversial. ...
Posted by Michael Wonder on 18 Oct 2018
Advancing toward the goal of global approval for generic drugs: FDA proposes critical first steps to harmonise the global scientific and technical standards for generic drugs
18 October 2018 - Too many Americans struggle with the high cost of drugs. In some cases, patients go without ...