Regulatory policy may not stop comparative efficacy trials

4 November 2020 - The way Sarfaraz K. Niazi, looks at it, doing comparative efficacy studies in humans to confirm that ...

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Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study

7 October 2020 - The investigators of the study set out to characterise the therapeutic value of new drugs approved ...

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FDA publishes comparative performance data for COVID-19 molecular diagnostic tests

15 September 2020 - Today, the U.S. FDA published comparative performance data for some authorised COVID-19 molecular diagnostic tests.  ...

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Biocon, Mylan launch Semglee and seek biosimilar, interchangeable status

31 August 2020 - For all intents and purposes, Semglee is a biosimilar insulin, but official biosimilar status is needed to ...

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Comparative assessment of clinical benefit using the ESMO Magnitude of Clinical Benefit Scale version 1.1 and the ASCO Value Framework Net Health Benefit Score

19 December 2018 - To better understand the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) ...

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FDA analysis shows similar success rates for paediatric trials using clinical and surrogate outcomes

21 August 2018 - An analysis by US FDA officials published earlier this month finds that there is a similar ...

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Are 'breakthrough' drugs as safe as other FDA approved medicines?

17 July 2018 - New research questions the quality of drugs given the "breakthrough therapy" designation by the US FDA.  ...

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How the U.S. compares to Europe on biosimilar approvals and products in the pipeline

2 May 2018 - FDA has not approved any biosimilar drug in 2018. ...

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Characteristics of interim publications of randomised clinical trials and comparison with final publications

23 January 2018 - Publication of interim results of randomised trials can be consequential, potentially undermining trial integrity by unblinding or ...

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New shingles vaccine endorsed over competitor by expert panel, a boost for GSK

25 October 2017 - The expert panel that helps guide U.S. vaccination policy has voted to give a preferential recommendation ...

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Gatekeeping strategies for avoiding false-positive results in clinical trials with many comparisons

10 October 2017 - Clinical trials characterizing the effects of an experimental therapy rarely have only a single outcome of interest. ...

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Challenges in international comparison of health care systems

27 July 2017 - International comparisons of health system performance exert major influence on the public and on policy makers.  ...

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Generic drug approvals since the 1984 Hatch-Waxman Act

6 September 2016 - This study, published in JAMA, uses US FDA data to identify approved generic drugs manufactured between September ...

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Cancer drugs are the least likely to receive FDA approval

26 May 2016 - But there’s good reason to hope that may change very soon. ...

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