Expanded Access Data Can Support Approval Decisions, US FDA Says

21 Nov 2018

• 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...