Blog
RSS FeedPosted by Michael Wonder on 24 Sep 2020
AstraZeneca boss says transparency key for vaccine
24 September 2020 - The chief executive of AstraZeneca has said the public must trust that multiple regulators will review ...
Posted by Michael Wonder on 22 Sep 2020
Taking steps toward transparency in real world evidence studies
22 September 2020 - The level of trust in health economics and outcomes research studies has been an on-going concern owing ...
Posted by Michael Wonder on 20 Aug 2020
Swiss data protection chief pushes back on drug pricing secrecy
20 August 2020 - A proposed change to the new health insurance law that seeks to keep drug prices under lock ...
Posted by Michael Wonder on 06 Aug 2020
Health experts to FDA: make your vaccine deliberations public
5 August 2020 - A letter signed by nearly 400 health experts asked the agency to use its vaccine advisory panel ...
Posted by Michael Wonder on 03 Jun 2020
EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication
1 June 2020 - In a response to officials at Germany’s IQWiG and the Cochrane Collaboration, EMA Executive Director Guido ...
Posted by Michael Wonder on 14 May 2020
Emergency use authorisation of remdesivir: the need for a transparent distribution process
14 May 2020 - On 4 February 2020, the Secretary of the US Department of Health and Human Services (DHHS) determined ...
Posted by Michael Wonder on 12 May 2020
FDA's drug approval system is more open than Australia's
11 May 2020 - Australia’s secretive drug approval system gives what some believe is an unfair advantage to rival drug companies. ...
Posted by Michael Wonder on 30 Apr 2020
TGA publishes more information about medicine formulations
30 April 2020 - To improve access to important medicine information, the Therapeutic Goods Administration now publishes additional formulation details ...
Posted by Michael Wonder on 08 Apr 2020
Submissions on whether the TGA should publish that a prescription medicine is under evaluation
8 April 2020 - Between 15 February and 29 March 2019, the TGA sought comments from interested parties on the ...
Posted by Michael Wonder on 24 Feb 2020
FDA launches new Purple Book searchable database to help patients and prescribers identify FDA-approved biologic and biosimilar treatment options
24 February 2020 - Today, the FDA is releasing the first phase of the enhancement of the “Purple Book: Database of ...
Posted by Michael Wonder on 29 Jan 2020
Documents disclosed to the EMA as part of an MA application process are not presumed to be confidential
28 January 2020 - On 22 January 2020 the CJEU handed down two decisions in which it decided that the ...
Posted by Michael Wonder on 22 Jan 2020
Court of Justice upholds EMA’s approach to transparency
22 January 2020 - EMA welcomes today’s two appellate judgments by the Court of Justice that confirmed, in clear and ...
Posted by Michael Wonder on 12 Oct 2019
Canada's decision to make public more clinical trial data puts pressure on FDA
11 October 2019 - Last March, Canada's department of health changed the way it handles the huge amount of data ...
Posted by Michael Wonder on 25 Aug 2019
Time for FDA to release complete responses letters? Debate reignites.
23 August 2019 - The idea of the US FDA releasing complete response letters resurfaced this week as Sarepta Therapeutics ...
Posted by Michael Wonder on 21 Aug 2019
Appealing court ruling, Trump administration renews fight to require drug prices in TV ads
21 August 2019 - The Trump administration isn’t giving up the fight to require drug makers include their sticker prices ...