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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NICE’s processes of technology evaluation - presenting a case for change

4 February 2021 - NICE has today launched a public consultation on proposals for changes to the processes it uses to ...

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New toolbox available for EMA's PRIME designees

2 February 2021 - The European Medicines Agency has released a draft guidance to assist drug developers using its Priority ...

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Qualitative comparative analysis of health economic evaluation guidelines for health technology assessment in European countries

10 December 2020 - Zisis and colleagues performed a literature review to identify published guidance for the conduct and assessment ...

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FDA offers guidance to enhance diversity in clinical trials, encourage inclusivity in medical product development

9 November 2020 - To further promote and protect public health, it is important that people who are in clinical trials ...

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NICE’s methods of technology evaluation - presenting a case for change

6 November 2020 - NICE has today launched a public consultation on proposals for changes to the methods it uses to ...

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IQWiG publishes a new version of its general methods

5 November 2020 - New features include the investigation of volume-outcome relationships and different mean observation times in clinical studies. ...

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FDA issues guidance on Emergency Use Authorisation for COVID-19 vaccines

6 October 2020 - Today, the U.S. FDA issued guidance with recommendations for vaccine sponsors regarding the scientific data and ...

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Biotech industry pushes Trump Administration to release new vaccine guidelines

2 October 2020 - The BIO trade group, whose members include most of the vaccine makers, asked the health secretary to ...

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Updated financial estimates workbook

30 September 2020 - An updated version of the Utilisation and Cost Model workbook and User Manual are now available to ...

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EMA close to finalising guidance for advanced therapies

16 September 2020 - The European Medicines Agency is on the verge of releasing revised guidance for advanced therapy medicinal ...

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FDA releases draft guidance on PROs for device manufacturers

31 August 2020 - Device manufacturers have new draft guidance from the US FDA for the selection of patient-reported outcome ...

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Consultation on the Medical Services Advisory Committee revised draft guidelines

31 August 2020 - The Department of Health is interested in obtaining views and feedback from the general public and ...

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