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Remote Working May Help Delay Retirement Of Senior US FDA Officials

 
• By Brenda Sandburg

CBER director Peter Marks notes efforts to bring in more staff to deal with ‘crushing’ workload; says there has been no political pressure for the center to approve COVID-19 booster shots.

remote working
US FDA expects growth in remote working • Source: Alamy

The move to remote working necessitated by the pandemic may help the US Food and Drug Administration retain senior staff who would otherwise retire, Center for Biologics Evaluation and Research Director Peter Marks noted.

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• By Sue Sutter

Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.

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Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Chikungunya At US CDC: Bavarian Nordic’s Vimkunya Recommended, Valneva’s Ixchiq Adjusted

 
• By Bridget Silverman

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