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Responding To Rx Drug Promo Violations: Tips From OPDP

 
• By Brenda Sandburg

US FDA's staff have sometimes worked late into the night to help sponsors meet deadlines and avoid errors in responding to a notice of violation. As is often the case, early communication helps avoid problems.  

deadline
FDA helps sponsors meet deadline to respond to compliance letters • Source: Shutterstock

Sponsors that receive US Food and Drug Administration letters objecting to an Rx drug advertisement would do well to seek early feedback in preparing their required response. This would help avoid making errors in their reply, missing the response deadline, and possibly receiving a rejection, an Office of Prescription Drug Promotion staffer advises.

“We’ve had cases where we’ve worked with sponsors until late at night on the deadline that their RNV [response to notice of violation] is due,” Jason Cober, OPDP's lead project...

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