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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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