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Expanded Access Data Can Support Approval Decisions, US FDA Says

 
• By Kate Rawson

Formal reg not needed, according to agency; officials agree that regulatory flexibility is best way to offer sponsors advice, saying data collected during compassionate use can be helpful in guiding regulatory decisions. 

Exercise
This is not an expanded access program that will help you get your product through the FDA.

The US FDA has a simple message for drug industry sponsors about establishing Expanded Access programs for patients outside clinical trials: compassionate use should be treated as an opportunity to enhance a product’s regulatory or commercial profile, rather than as a potential risk to approval.

Speaking during a Reagan-Udall Foundation meeting on Nov. 19 at FDA headquarters in White Oak, MD, top officials from across the agency’s drug and biologics centers were unanimous in their...

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