CADTH launches consultation on real world evidence reporting guidance

10 November 2022 - Today, CADTH, on behalf of the Real World Evidence Steering Committee, launched a public consultation to ...

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FDA finalises umbrella trial guidance for cell and gene therapies

4 November 2022 - The US FDA laid out its recommendations for sponsors to study multiple versions of a cellular or ...

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FDA finalises multiple endpoints guidance

20 October 2022 - The US FDA on Thursday finalised guidance to sponsors on managing multiple outcomes in clinical trials ...

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Tissue agnostic drug development in oncology

17 October 2022 - This guidance provides recommendations to sponsors regarding considerations for tissue agnostic drug development in oncology.  ...

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EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products

29 September 2022 - EMA is launching a pilot to support the translation of basic research developments into medicines that could ...

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Submitting documents using real world data and real world evidence to FDA for drug and biological products

8 September 2022 - To facilitate FDA’s internal tracking of submissions to the Agency that include real world data and real ...

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New handbook on health economic assessments of medical devices

18 August 2022 - TLV carries out health economic assessments of medical technology products at the request of the Medical Technology ...

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Regulatory considerations to keep pace with innovation in digital health products

19 August 2022 - Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital ...

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FDA offers new guidance on therapeutic equivalence evaluations

20 July 2022 - In draft guidance issued on Wednesday, the US FDA explains its approach to therapeutic equivalence evaluations and ...

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EMA finalises companion diagnostic guidance

7 July 2022 - The EMA) has finalised guidance on companion diagnostics, addressing procedural aspects to facilitate consultation between EMA ...

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Global expert panel publishes guidance on deliberative processes for health technology assessment

7 June 2022 - Value in Health announced today the publication of guidance regarding the establishment or improvement of deliberative ...

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NICE sets out further details on menopause guideline update

27 May 2022 - NICE has outlined what aspects of menopause care will be updated in upcoming guidance, including areas where ...

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Review of discount rate in the PBAC Guidelines

25 May 2022 - The Commonwealth has entered into a new Strategic Agreement in relation to reimbursement, health technology assessment ...

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EMA guidance supports development of new antibiotics

24 May 2022 - As part of its efforts to support a global approach to the development of new antimicrobial medicines, ...

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Methods paper: new version 6.1 becomes effective – English translation now available

2 May 2022 - The amendments concern, among other things, the approach to evidence searches for clinical practice guidelines. New ...

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