COVID-19 Health Authority updates
A summary of global health authorities updates in response to COVID-19.
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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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The 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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Against 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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The Future is Now Managing Clinical Trials in an Evolving Industry
There have been many advancements and changes in the way clinical trials are conducted—especially in the COVID-19 era. View this briefing to learn how Parexel continues to lead and reimagine the futur
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Highlights of Management Board: June 2021 meeting, MB, 18/06/2021
The Management Board heard from EMA about recent developments in response to COVID-19. Since the last update in March, a fourth vaccine (Janssen vaccine...
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CDER 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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Tofacitinib in Patients Hospitalized with Covid-19 Pneumonia
New England Journal of Medicine, Ahead of Print.
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mRNA Covid-19 Vaccines in Pregnant Women
New England Journal of Medicine, Volume 384, Issue 24, Page 2342-2343, June 2021.
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Spike D614G — A Candidate Vaccine Antigen Against Covid-19
New England Journal of Medicine, Volume 384, Issue 24, Page 2349-2351, June 2021.
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Audio Interview: Covid-19 in Children
New England Journal of Medicine, Volume 384, Issue 24, June 2021.
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Coronavirus (COVID-19) Update: June 15, 2021
Coronavirus (COVID-19) Update: June 15, 2021
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Coronavirus (COVID-19) Update: June 11, 2021
Coronavirus (COVID-19) Update: June 11, 2021
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FDA Takes Steps to Increase Availability of COVID-19 Vaccine
FDA authorized two batches of Janssen’s COVID-19 vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore
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COVID-19 Vaccine Janssen: authorities in EU take steps to safeguard vaccine quality, , 11/06/2021
Authorities in the EU are aware that a batch of the active substance for COVID-19 Vaccine Janssen had been contaminated with materials for another...
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Additional manufacturing capacity for Moderna’s COVID-19 vaccine, CHMP, 11/06/2021
EMA’s committee for human medicines (CHMP) has approved a new manufacturing site for the production of Moderna COVID-19 vaccine finished product. The...
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2021, PRAC, 11/06/2021
PRAC concludes review of signal of capillary leak syndrome with COVID-19 vaccine VaxzevriaEMA’s safety committee (PRAC) has concluded that people who...
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COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis, PRAC, 11/06/2021
EMA’s safety committee (PRAC) is continuing its assessment of reports of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of...
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International regulators and WHO address need to boost COVID-19 vaccine confidence, , 11/06/2021
The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) have jointly developed a statement to...
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Delayed Large Local Reactions to mRNA Covid-19 Vaccines in Blacks, Indigenous Persons, and People of Color
New England Journal of Medicine, Ahead of Print.
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Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19
New England Journal of Medicine, Ahead of Print.
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