COVID-19

Your central place to rapidly access latest news, translated guidance information, and expert interpretations from our former regulators related to COVID-19. Parexel’s 1000+ consulting experts are closely following agency announcements and new guidances and can help provide deep expertise and experience in the race to bring this outbreak to a close. We’re here to fight this with you.

  • COVID-19 daily Health Authority updates

    COVID-19 daily Health Authority updates

    Updated every day, in a single source

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  • Biosimilars in the time of COVID-19 and beyond

    Biosimilars in the time of COVID-19 and beyond

    Introduction The recent COVID-19 pandemic has triggered a race for pharmaceutical companies to repurpose their commercialized drugs approved for other clinical indications to treat patients...

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  • See Parexel's latest COVID-19 expert content

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  • Protective Antibody Therapy: Preventing Future COVID-19 Outbreaks

    Protective Antibody Therapy: Preventing Future COVID-19 Outbreaks

    About the Authors Dean Giovanniello, RPh., Vice President, co-leads the Health Advances Biopharma...

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  • Alternativa - 607147 - 05/26/2020

    Alternativa - 607147 - 05/26/2020

    Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

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  • Musthavemom.com - 607749 - 05/26/2020

    Musthavemom.com - 607749 - 05/26/2020

    Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

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  • Critical considerations for re-starting clinical trials in countries recovering after the COVID-19 pandemic

    Critical considerations for re-starting clinical trials in countries recovering after the COVID-19 pandemic

    The COVID-19 pandemic led to a variety of risk-based adjustments to clinical trial conduct. Mitigation measures had to be taken based on a risk assessment by sponsors and investigators in which...

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  • Careful Cents, LLC - 607756 - 05/26/2020

    Careful Cents, LLC - 607756 - 05/26/2020

    Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

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  • Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers

    Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers

    This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency.

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  • EMA commissions independent research to prepare for real-world monitoring of COVID-19 vaccines, , 27/05/2020

    EMA is engaging early with researchers to ensure that a European infrastructure will be in place to effectively monitor COVID-19 vaccines in the real...

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  • Coronavirus (COVID-19) Update: Daily Roundup May 26, 2020

    Coronavirus (COVID-19) Update: Daily Roundup May 26, 2020

    Coronavirus (COVID-19) Update: Daily Roundup

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  • Coronavirus (COVID-19) Update: Daily Roundup May 26, 2020

    Coronavirus (COVID-19) Update: Daily Roundup May 26, 2020

    Coronavirus (COVID-19) Update: Daily Roundup

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  • EMA calls for high-quality observational research in context of COVID-19, , 26/05/2020

    For observational studies of real world data in COVID-19, EMA calls for transparency for protocols and results, and collaboration between researchers...

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  • “Is It Safe for Me to Go to Work?” Risk Stratification for Workers during the Covid-19 Pandemic

    New England Journal of Medicine, Ahead of Print.

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  • Coronavirus (COVID-19) Update: Daily Roundup May 22, 2020

    Coronavirus (COVID-19) Update: Daily Roundup May 22, 2020

    Coronavirus (COVID-19) Update: Daily Roundup

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  • Managing Continuity in Clinical Trials in the COVID-19 environment:  The Decentralized Option and Regulatory Flexibility

    Managing Continuity in Clinical Trials in the COVID-19 environment: The Decentralized Option and Regulatory Flexibility

    Introduction/Situation COVID-19 has created a number of challenges in managing clinical trials for acute, chronic, life-threatening, and rare diseases. Due to the pandemic, as many as 90% of...

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  • Coronavirus (COVID-19) Update: Daily Roundup May 22, 2020

    Coronavirus (COVID-19) Update: Daily Roundup May 22, 2020

    Coronavirus (COVID-19) Update: Daily Roundup

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  • Remdesivir for the Treatment of Covid-19 — Preliminary Report

    New England Journal of Medicine, Ahead of Print.

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  • At least 80 million children under one at risk of diseases such as diphtheria, measles and polio as COVID-19 disrupts routine vaccination ef

    At least 80 million children under one at risk of diseases such as diphtheria, measles and polio as COVID-19 disrupts routine vaccination ef

          COVID 19 is disrupting life-saving immunization services around the world, putting millions of children – in rich and poor countries alike – at risk of diseases like diphtheria, measles and...

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  • North Coast Biologics - 607532 - 05/21/2020

    North Coast Biologics - 607532 - 05/21/2020

    Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

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  • Coronavirus (COVID-19) Update: Daily Roundup May 21, 2020

    Coronavirus (COVID-19) Update: Daily Roundup May 21, 2020

    Coronavirus (COVID-19) Update: Daily Roundup

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