Focus on Infectious Disease
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FDA Guides On Generic Development During COVID-19

FDA Guides On Generic Development During COVID-19

Source : 'Generics Bulletin'

The US Food and Drug Administration has published fresh guidance giving abbreviated new drug application developers advice on how to operate during the COVID-19 pandemic, in the form of a...

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UK Weathers Challenges Of COVID-19 And Brexit

UK Weathers Challenges Of COVID-19 And Brexit

Source : 'Generics Bulletin'

Over the past year, Brexit and the COVID-19 pandemic have represented two major threats to the smooth functioning of the UK generics and biosimilars market. And after discussing how far...

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Coronavirus Mutations: FDA Singles Out 4 Molecular Tests That Can Give False Readings

Coronavirus Mutations: FDA Singles Out 4 Molecular Tests That Can Give False Readings

Source : Medtech Insight

The US Food and Drug Administration has published a page on its website to update stakeholders about how mutations in the SARS-CoV-2 virus cause lower sensitivity of some COVID-19 tests...

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COVID-19: FDA Schedules 4 More Virtual Town Halls Through April

COVID-19: FDA Schedules 4 More Virtual Town Halls Through April

Source : Medtech Insight

The US Food and Drug Administration is continuing its run of virtual town halls aimed at labs and manufacturers that are (or have) developed diagnostic tests for COVID-19.

The FDA announced...

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BTG SP Makes A Virtue Of Manufacturing And Supply Discipline Despite COVID

BTG SP Makes A Virtue Of Manufacturing And Supply Discipline Despite COVID

Source : IN VIVO

No noise and no drama. It is a precept that has been keenly respected by the staff and management of BTG Specialty Pharma over the past few years, much to...