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US FDA v. COVID Mutants: Multi-Factorial Assessments Will Determine When Product EUAs Need To Change

 
• By Sarah Karlin-Smith

Acting Commissioner Janet Woodcock offers hints as to the content of upcoming guidance on how emerging virus variants may impact vaccine and therapeutic development. US may need multivalent vaccine and multiple boosters. 

COVID gears (shutterstock)
FDA is conducting wide-ranging scenario planning to deal with virus changes • Source: Shutterstock

The US Food and Drug Administration will be taking several factors into consideration as it decides whether to pull an emergency use authorization for COVID-19 therapeutics or require vaccines to be updated due to emerging variants of the SARS-CoV-2 virus.

Draft guidance on these topics should be available in several weeks, Acting Commissioner Janet Woodcock said on 4 February, and...

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Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.

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New EU Filings

 
• By Neena Brizmohun

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With Thyroid Petition Win, AbbVie Snares Itself; US FDA Sets Up Another Compounding Fight

 
• By Manas Mishra

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