Expediency versus efficacy: re-examining the FDA’s accelerated drug approval process

23 June 2022 - It was precisely 30 years ago, in 1992, that the FDA established the accelerated approval program ...

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FDA explains when it will rescind breakthrough designations

23 June 2022 - The US FDA on Thursday released draft guidance explaining its thought process for rescinding breakthrough therapy ...

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PHARMAC announces first round of medicine funding decisions following $191 million pharmaceutical budget increase

15 June 2022 - PHARMAC today announces the first round of changes to medicines funding following its $191 million pharmaceutical ...

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The days of the independent republic of PHARMAC are far from over

9 June 2022 - When he announced the government’s response to the recent independent review of PHARMAC Health Minister Andrew Little ...

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The FDA’s Pazdur on accelerated approval, single-arm studies and his own future

4 June 2022 - When cancer drugs granted accelerated approval in the U.S. later turn out not to benefit patients, the ...

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From scientific discovery to covered treatments: understanding the payer perspective as a keystone to achieving high value care

26 May 2022 - The mission of the National Institutes of Health is to translate scientific discovery into health by designing ...

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Target trial emulation for transparent and robust estimation of treatment effects for health technology assessment using real world data: opportunities and challenges

25 May 2022 - Evidence about the relative effects of new treatments is typically collected in randomised controlled trials.  ...

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Multiple funding proposals being considered by PHARMAC

19 May 2022 - PHARMAC has issued three consultations today on proposals to fund medicines for conditions including cancer, multiple sclerosis, ...

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Choices that fail health and wellbeing

5 May 2022 - NICE's expert group RAPID C-19, set up to ‘to ensure safe and timely patient access to treatments ...

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Real world evidence - where are we now?

4 May 2022 - Notwithstanding on-going confusion over the concepts of “real-world data” and “real-world evidence” in 2022, more than 5 ...

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Will the shadow of Aduhelm cloud FDA’s decision-making on an ALS therapy?

21 April 2022 - On March 30, an FDA advisory panel voted 6 to 4 against recommending approval of what ...

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FDA shuts out its own experts in authorising another vaccine booster

3 April 2022 - Decisions like this only reinforce the perception that Covid policy is driven by groupthink and politics. ...

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HIRA mulls therapeutic outcome based benefits for ultra-expensive drugs

9 February 2022 - Pharmaceutical industry officials are paying attention to how the Korean government will manage health insurance benefits ...

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Analysis of consumer comments into PBAC decision-making (2014–9)

4 February 2022 - Our objective was to analyse and review consumer comments in the PBAC's decision-making process. ...

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Addressing uncertainty in relative effectiveness assessments by HTA organisations

31 January 2022 - This study outlines the ways in which different health technology assessment organizations deal with uncertainty in relative ...

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