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.
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View NowCOVID-19 Health Authority updates
A summary of global health authorities updates in response to COVID-19.
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Learn MoreThe Special Approval Pathway (SAP) for COVID-19 related products in China
The regulatory pathway for COVID-19 drugs in China is governed by the Special Approval Program (SAP) which was introduced by National Medical Product Administration (NMPA) in 2005. SAP is...
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Learn MoreAgainst All Odds: Can Covid-19 Usher in a New Era in International Public Health Cooperation?
Key Takeaways The COVID-19 pandemic has drawn attention to international efforts to promote...
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Learn MoreCoronavirus (COVID-19) Update: April 9, 2021
The FDA recommends health care personnel and facilities transition from the use of decontaminated disposable respirators, and issues warning letters to two companies for selling unapproved...
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Learn MoreCDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19
CDER Scientific Reviews Supporting EUA for Therapeutic Products
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021, PRAC, 09/04/2021
PRAC conclusion on very rare cases of unusual blood clots with low blood platelets with Vaxzevria (AstraZeneca’s COVID-19 vaccine)EMA’s safety committee...
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Learn MoreAbout Mineral - 613984 - 04/07/2021
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
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Learn MoreAllure Imports - 613211 - 04/07/2021
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
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AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets, PRAC, 07/04/2021
EMA confirms overall benefit-risk remains positiveEMA’s safety committee (PRAC) has concluded today that unusual blood clots with low blood platelets...
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Preparing for the Future — Nanobodies for Covid-19?
New England Journal of Medicine, Ahead of Print.
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Learn MoreCoronavirus (COVID-19) Update: April 6, 2021
Coronavirus (COVID-19) Update: April 6, 2021
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Learn MoreCoronavirus (COVID-19) Update: April 6, 2021
Coronavirus (COVID-19) Update: April 6, 2021
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Learn MoreCoronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System.
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Learn MoreSparrow Health & Performance LLC - 608460 - 12/21/2020
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
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Antibody Persistence through 6 Months after the Second Dose of mRNA-1273 Vaccine for Covid-19
New England Journal of Medicine, Ahead of Print.
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Learn MoreDevelopment of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry
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Learn MoreCoronavirus (COVID-19) Update: April 2, 2021
Coronavirus (COVID-19) Update: April 2, 2021
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Learn MoreCoronavirus (COVID-19) Update: April 2, 2021
Coronavirus (COVID-19) Update: April 2, 2021
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Learn MoreNatural Adventure, LLC - 612267 - 04/01/2021
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
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Learn MoreCoronavirus (COVID-19) Update: FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization to Help Increase the Number o
The FDA announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine.
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