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    An Interview With CDER Director Janet Woodcock

    • 03 August 2018
    Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), answered a few questions by telephone from Focus on Friday afternoon. Below is a lightly edited transcript of the questions and answers.
     

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  • Dissolution Testing and Acceptance Criteria: FDA Finalizes Guidance

    • 08 August 2018
    The US Food and Drug Administration (FDA) on Wednesday released final guidance for sponsors on when a standard release test and criteria may be used in lieu of extensive method development and acceptance criteria-setting exercises.
     

  • EMA Updates on Recalled Valsartan Medicines

    • 02 August 2018
    An initial health risk assessment conducted by the European Medicines Agency (EMA) projects a hypothetical increase in cancer cases among patients who took certain medicines with a Chinese company’s active substance that was previously found to contain an impurity.
     

  • Brexit Guidance: MHRA Outlines What to Expect

    • 06 August 2018
    The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Monday explained what life science companies can expect during the period that the Brexit agreement is implemented.
     

  • FDA’s CDER Unveils Details of Reorganization

    • 19 July 2018
    The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) on Thursday announced the details of a major reorganization, affecting nearly one-third of CDER.
     
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About Regulatory Focus

Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products.

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