In a rare move, FDA threatens to fine a company for failing to report clinical trial results

16 August 2023 - For only the fifth time, the FDA recently threatened to fine a company or clinical trial ...

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20 July 2022 - In draft guidance issued on Wednesday, the US FDA explains its approach to therapeutic equivalence evaluations and ...

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FDA drafts guidance on genome editing, CAR T cell therapies

16 March 2022 - The U.S. FDA has issued two draft guidances addressing the development of human gene therapy products that ...

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Office of Generic Drugs 2021 Annual Report

14 February 2022 - Ensuring high quality, affordable generic drugs are available to the American public. ...

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FDA enforces ClinicalTrials.gov results posting requirements, including threats of financial penalty

27 January 2022 - Clinical trials requiring registration on ClinicalTrials.gov generally must have results submitted no later than one year after ...

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COVID-19 vaccines and treatments: we must have raw data, now

19 January 2022 - Data should be fully and immediately available for public scrutiny ...

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Advancing health through innovation: new drug therapy approvals 2021

13 January 2022 - The FDA’s Center for Drug Evaluation and Research has issued its report, Advancing Health Through Innovation: New ...

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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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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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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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