Blog
RSS FeedPosted by Michael Wonder on 18 Jun 2020
US court nixes drug maker price disclosure
18 June 2020 - A US court has ruled against a move by President Donald Trump's administration to try to bring ...
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 03 May 2020
Agenda for the July 2020 PBAC meeting (revised)
1 May 2020 - Published on Wednesday and revised (with no notification) by Friday. ...
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 31 Mar 2020
1 April 2020 price disclosure confirmed prices
31 March 2020 - Confirmed 1 April 2020 prices resulting from the 2020 April cycle of price disclosure have been published ...
Posted by Michael Wonder on 05 Mar 2020
Standardised redactions to Public Summary Documents – nominations open for participation in the final trial, and implementation from July 2020
5 March 2020 - The Department is now seeking nominations from sponsors with submissions due to be considered at 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 03 Feb 2020
2020 April price disclosure cycle - indicative prices
3 February 2020 - Indicative 1 April 2020 prices resulting from the 2020 April Cycle of Price Disclosure have now been ...
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 20 Jan 2020
Talkin’ about a resolution: issues in the push for greater transparency of medicine prices
20 January 2020 - At the 2019 World Health Assembly, a significant new resolution was agreed by most countries to start ...
Posted by Michael Wonder on 10 Jan 2020
Defending transparency at European drug regulator
8 January 2020 - Forthcoming judgment must uphold public access to clinical data ...