FDA issues final guidance on considerations for the use of real world data and real world evidence to support regulatory decision-making for drugs and biological products

30 August 2023 - Today, the US FDA issued a final guidance for industry titled Considerations for the Use of Real-World ...

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

26 May 2023 - This final guidance describes FDA’s current recommendations regarding adjusting for covariates in the statistical analysis of randomised ...

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Guidance for industry to prevent and mitigate medicine shortages

17 May 2023 - EMA has published recommendations for industry on good practices to ensure continuity in the supply of ...

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Clinical trial considerations to support accelerated approval of oncology therapeutics

24 March 2023 - The accelerated approval pathway is commonly used for approval of oncology drugs due to the serious ...

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FDA outlines plan for digital health technologies for clinical trials

24 March 2023 - The US FDA plans to hold at least one public meeting and release several guidances on digital ...

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Stakeholders want more clarity on FDA's statistical approach to assessing bioequivalence

7 February 2023 - Commenters on the US FDA draft guidance outlining principles for in vivo or in vitro bioequivalence ...

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Draft guidance document on the collection and analysis of disaggregated data in clinical trials: transparency

16 December 2022 - This guidance will help sponsors interpret amendments to the Food and Drug Regulations (regulations) requiring them ...

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Facilitating decentralised clinical trials in the EU

19 December 2022 - The European Commission, the Heads of Medicines Agencies and the EMA have published recommendations that aim 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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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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