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    Preparing for successful meetings with the FDA

    • 02 January 2019
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    Meeting with the FDA offers sponsors an opportunity to seek out critical feedback, provide background on their product and demonstrate the effectiveness of their studies. The right experience, preparation and planning is necessary to make the most of these meetings and help ensure a level of confidence with the FDA. Read on to learn about the three types of FDA meetings and gain insights for optimizing these opportunities. Read the full article>>
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    The Role of BPOG Extractables Data in the Effective Adoption of Single-Use Systems

    In recent years, pharmaceuticals have become more complex, progressing from primarily small molecule drugs to an increasing array of recombinant proteins, monoclonal antibodies and cell and gene therapies. This has led to necessary changes in regulations to accommodate new, more complex manufacturing processes that have more steps and are more sensitive to variability and contamination. …. Read the full white paper