Hamburg pushes toward "strong FDA"

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 [1]
- here's the text [2]

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