Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations

11 January 2022 - The new CHEERS 2022 statement replaces previous CHEERS reporting guidance.  ...

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NICE recommends offering PrEP to people at high risk of HIV for first time

15 December 2021 - People at the highest risk of catching HIV should be offered pre-exposure prophylaxis, NICE has recommended for ...

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FDA publishes discussion paper and seeks public input on 3D printing of medical devices at the point of care

10 December 2021 - Today, the U.S. FDA published a discussion paper regarding 3D printing medical devices at the point of ...

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FDA issues draft guidance: assessing registries to support regulatory decision-making for drug and biological products

29 November 2021 - Today, the U.S. FDA issued a draft guidance for industry titled "Real-World Data: Assessing Registries to Support ...

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Can we trust strong recommendations based on low quality evidence?

25 November 2021 - A necessary requirement for development of trustworthy guidelines is to respect the relation between the quality (certainty) ...

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Strengthening the reporting of observational studies in epidemiology using Mendelian randomisation: the STROBE-MR Statement

26 October 2021 - An international expert committee, informed by the methodological framework for guideline development of the Enhancing the Quality ...

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FDA issues draft guidance for industry on data standards for drug and biological product submissions containing real world data

21 October 2021 - Today, the U.S. FDA issued a draft guidance for industry titled Data Standards for Drug and Biological ...

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Updates to the procedure guidance for listing medicines on the PBS

15 October 2021 - The Department has updated Section 5.8 New brand of existing pharmaceutical item submissions (not requiring PBAC consideration) ...

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Benefit-risk assessment for new drug and biological products

29 September 2021 - The intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about ...

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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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