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US FDA’s Two-Month Safety Window For COVID Vaccines Based On Adverse Events In Other Products

 
• By Sue Sutter and Bridget Silverman

In remarks fleshing out the ‘EUA Plus’ guidance before it became a political football, Operation Warp Speed’s Slaoui said that an FDA analysis concluded that 90% of adverse events related to vaccination take place within the first 42 days.

Moncef Slaoui at White House press briefing
Moncef Slaoui speaks at a White House press briefing earlier this year.

Moncef Slaoui, chief scientific officer to Operation Warp Speed, said that the US FDA’s standard for a two-month safety follow-up on coronavirus vaccines is based on adverse event patterns seen with other vaccines.

Speaking to the National Vaccine Advisory Committee on 23 September, just hours before President Trump would criticize the benchmark, Slaoui seemed unaware

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House Budget Bill Includes Delayed Orphan Fix, Also Risks Downstream Cell and Gene Coverage

 
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The first two classes of negotiated drugs under the Inflation Reduction Act would not benefit from a rare disease adjustment House Republicans included in their reconciliation package.

Trump’s Rx Pricing Order: The Best-Case And Worst-Case Scenarios

 
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Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

UK’s International Recognition Procedure: EU Dossier Faster Than US Or Canada

 
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FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 
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