Leading by example on her promise of transparency at the Food and Drug Administration, Commissioner Margaret Hamburg spoke publicly on her recent actions and plans for a strong FDA. Speaking from prepared remarks at the Food and Drug Law Institute in Washington last week, she outlined the first six steps toward that objective.
"Again and again, I heard support for a strong FDA," says Hamburg, of meeting with stakeholders during her first eight weeks in the position.
Perhaps most significant is a new procedural process by the regulator for corrections made after an inspection found violations leading to a warning letter. It's a formal close-out process in which the FDA certifies that the corrections have been made. "To keep the public informed, we will indicate on our website when a firm has received a close-out letter," says Hamburg. "I hope that receiving a close-out letter quickly becomes a top industry priority."
She says the FDA will also begin setting post-inspection deadlines. When the FDA finds a company significantly out of compliance, that company "will generally have no more than 15 working days in which to respond before the FDA moves ahead with a warning letter or enforcement action," explained Hamburg. "This will help FDA issue warning letters on a timely basis and facilitate prompt corrective action."
- see Hamburg's talk in a 25-minute web cast
- here's the text