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.
-
View NowCOVID-19 Health Authority updates
A summary of global health authorities updates in response to COVID-19.
-
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...
-
See Parexel's latest COVID-19 expert content
View all -
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...
-
Learn MoreCoronavirus (COVID-19) Update: FDA Continues Important Work to Support Medical Product Development to Address New Virus Variants
FDA Continues Important Work to Support Medical Product Development to Address New Virus Variants
-
Visit Parexel's COVID 19 Clearinghouse
Visit Now -
Learn MoreCoronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine
Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine
-
Learn More
Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers , CHMP, 25/02/2021
EMA has issued guidance outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in order to address coronavirus (SARS-CoV...
-
Learn More
International cooperation to align approaches for regulation of COVID-19 vaccines and medicines, , 25/02/2021
Regulators around the globe are committed to aligning their regulatory requirements and addressing knowledge gaps to facilitate the development,...
-
Learn More
Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19
New England Journal of Medicine, Ahead of Print.
-
Learn More
Tocilizumab in Hospitalized Patients with Severe Covid-19 Pneumonia
New England Journal of Medicine, Ahead of Print.
-
Learn More
Interleukin-6 Receptor Inhibition in Covid-19 — Cooling the Inflammatory Soup
New England Journal of Medicine, Ahead of Print.
-
Learn More
EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19, , 24/02/2021
EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the monoclonal antibody regdanvimab (also known as CT-P59), which is...
-
Learn More
BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting
New England Journal of Medicine, Ahead of Print.
-
Learn More
Audio Interview: The Real-World Effectiveness of Covid-19 Vaccination
New England Journal of Medicine, Volume 384, Issue 8, February 2021.
-
Learn MoreCoronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants
Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants
-
Learn MoreCoronavirus (COVID-19) Update: February 23, 2021
Coronavirus (COVID-19) Update: February 23, 2021
-
Learn MoreCoronavirus (COVID-19) Update: February 23, 2021
Coronavirus (COVID-19) Update: February 23, 2021
-
Learn More
EMA starts evaluating use of Veklury in COVID-19 patients not requiring supplemental oxygen, CHMP, 23/02/2021
EMA has started evaluating an application to extend the use of Veklury (remdesivir) to include treating adults with COVID-19 who do not require...
-
Learn MoreCoronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants
Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants
-
Learn MoreCoronavirus (COVID-19) Update: February 19, 2021
Coronavirus (COVID-19) Update: February 19, 2021
-
Learn MoreCDER’s Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law on March 27, 2020 to aid response efforts and ease the economic impact of COVID-19.
-
Loading More...
