Focus on Infectious Disease
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The COVID Boom: CBER Receives More INDs in One Quarter Than The Previous 30 Combined

The COVID Boom: CBER Receives More INDs in One Quarter Than The Previous 30 Combined

Source : 'The Pink Sheet'

The coronavirus pandemic attracted a historic tsunami of investigational work to the US Food and Drug Administration’s Center for Biologics Evaluation and Research, which may affect its operations even after...

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Has UK Got Vaccine Strategy Right Again With Choice For Under 30s?

Has UK Got Vaccine Strategy Right Again With Choice For Under 30s?

Source : 'The Pink Sheet'

The UK has achieved one of the fastest and most successful COVID-19 vaccination programs anywhere in the world so far, thanks to its early procurement deals with manufacturers, and a...

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Coronavirus Notebook: EMA Probes Janssen Vaccine Blood Clot Reports, UK Advises 12-Week Dosing Gap For Moderna

Coronavirus Notebook: EMA Probes Janssen Vaccine Blood Clot Reports, UK Advises 12-Week Dosing Gap For Moderna

Source : 'The Pink Sheet'

It's been a big week for safety updates on the coronavirus vaccine front.

After UK and EU regulators warned of the risk of unusual blood clots combined with low platelet...

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Pink Sheet Podcast: EUA’s Impact On US FDA, March-In Rights, CBER And Real-Time Oncology Review

Pink Sheet Podcast: EUA’s Impact On US FDA, March-In Rights, CBER And Real-Time Oncology Review

Source : 'The Pink Sheet'

Pink Sheet senior writers Derrick Gingery and Sarah Karlin-Smith and Executive Editor Nielsen Hobbs discuss the impact of the US Food and Drug Administration’s experience with the emergency use authorization...