Last updated 18th December 2020
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Last updated 18th December 2020
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...
CDER Scientific Reviews Supporting EUA for Therapeutic Products
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...
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
EMA confirms overall benefit-risk remains positiveEMA’s safety committee (PRAC) has concluded today that unusual blood clots with low blood platelets...
New England Journal of Medicine, Ahead of Print.
Coronavirus (COVID-19) Update: April 6, 2021
Coronavirus (COVID-19) Update: April 6, 2021
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System.
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
New England Journal of Medicine, Ahead of Print.
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry
Coronavirus (COVID-19) Update: April 2, 2021
Coronavirus (COVID-19) Update: April 2, 2021
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
The FDA announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine.
FDA Continues to Advance Over-the Counter and Other Screening Test Development.
EMA’s safety committee (PRAC) is meeting today, Wednesday 31 March, in the context of its ongoing review of very rare cases of unusual blood clots...
New England Journal of Medicine, Volume 384, Issue 13, April 2021.
