Price disclosure October 2020 cycle outcomes summary

25 June 2020 - The summary of price disclosure price reductions for the October 2020 Cycle has now been published. ...

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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 ...

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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 ...

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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 ...

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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. ...

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Agenda for the July 2020 PBAC meeting (revised)

1 May 2020 - Published on Wednesday and revised (with no notification) by Friday. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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