“[The issue has raised] many difficult and novel policy and regulatory issues, ... We need to resolve these policy and regulatory questions before we can reach a decision on the underlying science.”
“There are unique regulatory issues that need to be addressed, ... We can only decide these issues in an open process. That will let us decide whether FDA can approve a drug for both over-the-counter and prescription use, for the same indication, sold in the same package.”
“Previous shortages highlighted the need for additional influenza vaccine manufacturers for the U.S. market, ... Accelerated approval has allowed us to evaluate and approve Fluarix in record time so that we can make available additional safe and effective flu vaccines.”
“Accelerated approval has allowed us to evaluate and approve Fluarix in record time so that we can make available additional safe and effective flu vaccines, ... I commend our Center for Biologics for taking extraordinary steps to help us be better prepared for both the upcoming and future flu seasons.”
“I also must thank the extraordinary people of FDA for the honor of having served with them, ... They have made public service a joy and a pleasure as we worked together to accomplish great things for public health.”