Method paper: IQWiG puts draft version 6.1 up for discussion

23 August 2021 - The IQWiG has presented the draft for the next version of its General Methods.  ...

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Final guidance on metastasis-free survival in non-metastatic castration resistant prostate cancer released by the FDA

10 August 2021 - The FDA announced its finalised guidance on the use of metastases-free survival as an outcome for ...

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Updated financial estimates workbook

6 August 2021 - An updated version of the Utilisation and Cost Model workbook is now available to support PBAC submissions. ...

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Collecting patient reported outcomes in cancer clinical trials

3 August 2021 - To help patients with cancer learn more about how treatment may affect their quality of life, the ...

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Update of handbook for companies applying for a subsidy

18 June 2021 - The Swedish Dental and Pharmaceutical Benefits Agency, TLV, has updated parts of the handbook for companies ...

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MSAC consultation process - changes to take effect from 1 July 2021

16 June 2021 - MSAC is implementing changes to its consultation process from 1 July 2021.  ...

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MSAC Technical Guidelines - release of guidelines for preparing assessments for the Medical Services Advisory Committee (Version 1.0, May 2021)

16 June 2021 - The Department of Health is pleased to announce the publication of the Guidelines for Preparing Assessments ...

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Core patient reported outcomes in cancer clinical trials

9 June 2021 - This guidance provides recommendations to sponsors for collection of a core set of patient reported clinical outcomes ...

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FDA announces draft guidances to help increase transparency, assist reporting and timely completion for certain medical device studies after FDA approval or clearance

26 May 2021 - Today, the U.S. FDA issued two guidances regarding the surveillance of certain medical devices. ...

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Adjusting for covariates in randomised clinical trials for drugs and biological products

20 May 2021 - This guidance represents FDA’s current thinking on adjusting for covariates in the statistical analysis of randomised clinical ...

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New recommendations on the critical appraisal of systematic reviews with cost and cost effectiveness outcomes

13 April 2021 - ISPOR announced today the publication of new guidance on how to evaluate the quality and risk ...

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NICE publishes single guideline for managing COVID-19

23 March 2021 - One year on from the first national lockdown, NICE has today published a single guideline for the ...

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Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers

25 February 2021 - EMA has issued guidance outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in ...

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Modifying NICE’s approach to equity weighting

7 February 2021 - The UK’s NICE recently launched a consultation on the methods it uses to evaluate new health technologies, ...

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NICE’s discounting review: clear thinking on rational revision meets obstacle of industrial interests

7 February 2021 - NICE recently published a review of discounting practice and theory as part of a consultation on ...

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