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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  • COVID-19: Gastrointestinal and hepatic manifestations and implications for clinical trials

    COVID-19: Gastrointestinal and hepatic manifestations and implications for clinical trials

    Parexel expert Michelle Pietzak, MD reviews current findings and offers practical recommendations for gastrointestinal symptoms of COVID-19 and considerations for clinical trials.

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  • Coronavirus (COVID-19) Update: Daily Roundup May 29, 2020

    Coronavirus (COVID-19) Update: Daily Roundup May 29, 2020

    Coronavirus (COVID-19) Update: Daily Roundup

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  • Coronavirus (COVID-19) Update: Daily Roundup May 29, 2020

    Coronavirus (COVID-19) Update: Daily Roundup May 29, 2020

    Coronavirus (COVID-19) Update: Daily Roundup

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  • Bringing a Cancer Doctor’s Perspective to FDA’s Response to the COVID-19 Pandemic

    Bringing a Cancer Doctor’s Perspective to FDA’s Response to the COVID-19 Pandemic

    During the unprecedented COVID-19 pandemic, the FDA recognizes that there has been public interest around expediting the development and availability of a number of potential treatment options.

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  • Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19

    Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19

    There are no FDA-approved coronavirus preventions or treatments. Researchers are studying new drugs, and drugs approved for other conditions, as possible preventions or treatments for COVID-19....

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  • International community rallies to support open research and science to fight COVID-19

    International community rallies to support open research and science to fight COVID-19

    WHO and Costa Rica launch landmark COVID-19 Technology Access PoolThirty countries and multiple international partners and institutions have signed up to support the COVID-19 Technology Access...

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  • Coronavirus (COVID-19) Update: FDA Takes Steps to Streamline Development of Tests With At-Home Sample Collection

    Coronavirus (COVID-19) Update: FDA Takes Steps to Streamline Development of Tests With At-Home Sample Collection

    FDA taking steps to further support the development of COVID-19 tests for at-home self-collection by including a voluntary EUA template for at-home sample collection kits to its website.

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  • StayWell Copper Products - 607773 - 05/28/2020

    StayWell Copper Products - 607773 - 05/28/2020

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

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  • Quadrant Sales & Marketing, Inc. - 607625 - 05/28/2020

    Quadrant Sales & Marketing, Inc. - 607625 - 05/28/2020

    Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)

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  • COVID-19: reminder of the risks of chloroquine and hydroxychloroquine , , 29/05/2020

    EMA is reminding healthcare professionals to closely monitor patients with COVID-19 who are receiving chloroquine or hydroxychloroquine, given the...

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  • Screening for Covid-19 in Skilled Nursing Facilities

    New England Journal of Medicine, Ahead of Print.

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  • Coronavirus (COVID-19) Update: Daily Roundup May 28, 2020

    Coronavirus (COVID-19) Update: Daily Roundup May 28, 2020

    Coronavirus (COVID-19) Update: Daily Roundup

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  • Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3, , 28/05/2020

    As part of its coordinated response to the pandemic, the International Coalition of Medicines Regulatory Authorities (ICMRA) convened its regular high-...

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  • Alternavita - 607147 - 05/26/2020

    Alternavita - 607147 - 05/26/2020

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

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  • Essential work to combat the COVID-19 pandemic to continue during EMA's closure on 1 June 2020, , 28/05/2020

    EMA has put measures in place to ensure that its activities related to the COVID-19 pandemic can continue during the Agency's closure on 1 June 2020....

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  • European medicines regulatory network fully mobilised in fight against COVID-19, , 28/05/2020

    The development and availability of medicines and vaccines for all patients in the European Union, including those with COVID-19, is the number one...

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  • COVID-19 intensifies the urgency to expand sustainable energy solutions worldwide

    COVID-19 intensifies the urgency to expand sustainable energy solutions worldwide

    Despite accelerated progress over the past decade, the world will fall short of ensuring universal access to affordable, reliable, sustainable, and modern energy by 2030 unless efforts are scaled...

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