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  • The impact of COVID-19 on clinical trials in rare disease and oncology

    The impact of COVID-19 on clinical trials in rare disease and oncology

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  • The New Pragmatism: Clinical Trials, Investment and Regulations Post-COVID-19

    The New Pragmatism: Clinical Trials, Investment and Regulations Post-COVID-19

    Once the COVID-19 pandemic passes or is contained, the world will look and work very differently. The biopharmaceutical industry is no exception. In this podcast, Peyton Howell, Parexel’s Chief...

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  • Patient engagement: Being heard3:04

    Patient engagement: Being heard

    Parexel’s Leslie DeVos and Katie Connelly both VP’s of Regulatory & Access have a heartfelt conversation with Lennie & Denny Woods, Parents & Co-Founders of Sara’s Cure (https://sarascure.org/), of th

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  • See Parexel's latest COVID-19 expert content

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  • Drug Development for Rare Disease and Oncology During the COVID-19 Pandemic

    Drug Development for Rare Disease and Oncology During the COVID-19 Pandemic

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  • Early Demise of FDA is Exaggerated – Highlights from the FDLI Annual Meeting

    Early Demise of FDA is Exaggerated – Highlights from the FDLI Annual Meeting

    Despite the best efforts of the pandemic, the FDLI delayed but did not cancel its annual meeting for 2020 and hosted the event through a virtual platform. In this blog, I’ll walk through the...

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  • Virtual meetings are easy, right?

    Virtual meetings are easy, right?

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  • Never Too Late to Join the Party – FDA Publishes Extensive Guidance on Control of Nitrosamine Impurities

    Never Too Late to Join the Party – FDA Publishes Extensive Guidance on Control of Nitrosamine Impurities

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  • Parexel on the Pulse1:49

    Parexel on the Pulse

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  • How Fair is FDA in Enforcement? Stacking Up the Agency Against a New Memo from the White House

    How Fair is FDA in Enforcement? Stacking Up the Agency Against a New Memo from the White House

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  • Five points to remember if FDA issues a Form 483

    Five points to remember if FDA issues a Form 483

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  • The Move Toward Global Standards: Navigating New EAEU Guidelines

    The Move Toward Global Standards: Navigating New EAEU Guidelines

    As the pandemic clearly revealed, there is an urgent need for a more cohesive, coordinated approach to streamline global regulatory guidelines to ensure patients have faster access to new and...

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  • How to interact virtually with health authorities

    How to interact virtually with health authorities

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  • I Can See More Clearly Now – FDA Issues Needed Guidance on Inspection Policies During COVID-19

    I Can See More Clearly Now – FDA Issues Needed Guidance on Inspection Policies During COVID-19

    On August 19, FDA published the final guidance Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers. You can find...

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  • An overview of the recent Executive Order on Critical Drugs Made in America

    An overview of the recent Executive Order on Critical Drugs Made in America

    On August 6, 2020 the president of the United States signed an Executive Order (EO) on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States. The...

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  • eBook: Biopharma in the COVID-19 World

    eBook: Biopharma in the COVID-19 World

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  • NMPA Guidance on the Management of Clinical Trials during the COVID-19 from July 2020

    NMPA Guidance on the Management of Clinical Trials during the COVID-19 from July 2020

    Conducting clinical trials during the COVID-19 pandemic has produced many challenges globally. The initiation, conduct, implementation and completion of a trial during this time requires special...

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  • Top 10 Myths About Working with the FDA for an Oncology Drug Approval

    Top 10 Myths About Working with the FDA for an Oncology Drug Approval

    Among biotech companies, a primary concern is how to establish a clinical strategy for scientific and commercial success at the earliest stage. In that respect, regulatory considerations figure...

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  • GxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”

    GxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”

    As global regulatory agencies are preparing to return to on-site inspections1, industry needs to be ready. With the continued threat of COVID-19, the way inspections will be performed and hosted...

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  • Will the FDA “CARE” More About Your Supply Chain?

    Will the FDA “CARE” More About Your Supply Chain?

    On March 27, 2020 the president of the United States signed into law the Coronavirus Aid, Relief and Economic Security (CARES) Act in response to the emerging pandemic (a copy of the public law...

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  • Has EMA started a domino effect for more regulation of API manufacturing?

    Has EMA started a domino effect for more regulation of API manufacturing?

    On June 23, 2020 the European Medicines Agency (EMA) released a report on lessons learned from the presence of N-nitrosamine impurities in angiotensin II receptor blocker drugs. You can find a...

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