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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 use setting and that such events will not constitute a 'kiss of death' in the eyes of the regulator," Alison Bateman-House, a

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