What is FDA's role in the development, testing, and monitoring of new drugs?
John Jenkins is Director of the Office of New Drugs at the Center for Drug Evaluation and Research. "It's very important for people to understand," says Jenkins, "that we don't know everything about new drugs at the time we approve them.... [I]f we waited until we knew everything you could possibly know, then the wait would be too long, and patients would be denied access to important new treatments." Today, Jenkins notes, the FDA has "several initiatives underway where we're trying to leverage the information we know and the expertise we have in house and work with partners outside the agency to improve health outcomes." That he adds is "...why those of us who work here, work here, because we want to have an impact on patients and public health."