FDA streamlines process for Warning Letters

Share this article:
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.”
Share this article:
close

Next Article in Features

Email Newsletters

More in Features

Antidote: On Cystic Fibrosis treatments

Antidote: On Cystic Fibrosis treatments

Recent treatments in CF, including the inhaled antibiotic Tobramycin, have increased lifespan well into adulthood.

The $3 generic and the $1,000 pill: pharma outsiders just don't get it

The $3 generic and the $1,000 pill: pharma ...

What do you call the people who treat medical breakthroughs as if they were bank heists? Malicious? Uninformed? Not with it?

Leadership Exchange Uncut : The Agency-Client Relationship

Leadership Exchange Uncut : The Agency-Client Relationship

Click the above link to access MM&M's first Leadership Exchange Uncut e-book, "The Agency-Client Relationship"