Coronavirus Notebook: UK Pledges To Donate Surplus Vaccines, UN Chief Wants Global Vaccination Plan
Source : 'The Pink Sheet'
This week has seen a flurry of declarations of support for efforts to ensure the equitable distribution of COVID-19 vaccines amid concern that lower and middle-income countries are being pushed...
Pink Sheet Podcast: Dsuvia Warning Letter, Refuse-To-File Impact, CDER’s COVID Workload
Source : 'The Pink Sheet'
Pink Sheet senior writers Derrick Gingery and Sarah Karlin-Smith and Executive Editor Nielsen Hobbs discuss the political and practical implications of the US Food and Drug Administration’s warning letter on...
How Genentech Pivoted To Digital During The Pandemic
Source : 'The Pink Sheet'
Pandemic travel restrictions accelerated Genentech, Inc. deployment of digital technologies like head-mounted tablets, Benedicte Lebreton, Genentech’s head of CMC regulatory for biologics development, told a recent CASSS WCBP workshop...
US FDA Could Be Facing Bolus Of Pandemic-Related Applications
Source : 'The Pink Sheet'
Increasing coronavirus vaccinations suggest contemplation of a post-pandemic life and a return to normal. The US Food and Drug Administration’s Center for Drug Evaluation and Research cannot anticipate that quite...
Coronavirus Notebook: UK To Start World’s First COVID-19 Challenge Study, Janssen Files Its Vaccine For EU Approval
Source : 'The Pink Sheet'
The UK’s clinical trials ethics body has given the go-ahead to the world’s first COVID-19 human challenge study in an effort to better understand how the virus works in the...