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Expanded Access Programs Need FDA Policy Changes To Really Expand

 
• By Sue Sutter

Agency should issue statement that deaths occurring during compassionate use will not automatically penalize a drug's development, ethicists from NYU Langone Medical Center say.

As FDA weighs the creation of an Expanded Access Navigator program, an independent panel's leaders say written assurance that adverse events will not damage a drug's prospects for continued development or approval would have far more impact in enabling pre-approval access for desperate patients.

FDA should "publish a statement assuring companies that the agency understands serious adverse events can and will happen in compassionate...

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Ex-CDC Leaders Reveal New Details Of Kennedy’s Plans For ACIP, Vaccine Schedule

 
• By Sarah Karlin-Smith

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More from North America

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• By Sarah Karlin-Smith

The former CDC director and recently departed chief medical officer tell senators that Kennedy plans to target the childhood vaccine schedule despite a lack of scientific data to support his agenda.

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• By Sue Sutter

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