FDA streamlines process for Warning Letters

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The days of getting an FDA Warning Letter after the subject promotional campaign has concluded may be over, if new internal initiatives to collapse the operational timeframes in the drug center's compliance and enforcement sectors bear fruit.

For years, FDA slowness in catching up with regulatory violations could be “taken to the bank.” When a letter eventually arrived from the agency, the matter complained about had frequently run its natural course and the expense of explaining this to FDA could be written off as a “cost of doing business.”

Since her enforcement initiative was announced, commissioner Margaret Hamburg has been directing resources into pressure points, including the CDER's Office of Compliance and the DDMAC.

“We have streamlined our processes for the drafting and review of untitled and warning letters,” DDMAC director Tom Abrams said in June. “We have also dedicated additional resources to enforcement. As a result we have a significant increase in these letters and they have become more timely.”

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