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    Drugmakers Seek Clarity on Guidance on Use of Placebo and Blinding in Oncology Trials

    A half-dozen biopharma companies are seeking further clarity from the US Food and Drug Administration (FDA) regarding draft guidance from August on using a placebo in certain oncology trials. The draft features FDA’s thoughts on the ethical challenges of using a placebo in randomized controlled clinical trials for therapies to treat hematologic malignancy and oncologic disease. The draft also discusses blinding and unblinding, patient reported outcomes (PROs) and prac...
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    Small Biopharma Face Distinct Challenges: FDA Official and Sanofi Genzyme SVP Argue

    Small biopharmaceutical companies, often known as the drivers of innovation, face a number of unique challenges in bringing new treatments, particularly for rare diseases, to market, Richard Moscicki, deputy director for science operations at the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, and P.K. Tandon, senior vice president of Sanofi Genzyme, wrote. In an article published Tuesday in the New England Journal of Medicine , the a...
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    When can Non-Inferiority Trials Establish Efficacy? FDA Explains With Guidance

    The US Food and Drug Administration (FDA) on Monday finalized guidance to pharmaceutical and biotech sponsors looking for more advice on when non-inferiority studies demonstrating effectiveness of an investigational drug can provide interpretable results, how to choose the non-inferiority margin and how to test the non-inferiority hypothesis. The 56-page guidance, which finalizes a draft from 2010 and supersedes the 2010 guidance known as "Antibacterial Drug Products: U...