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PDUFA V: Communications Liaisons Will Help Find Answers, Not Give Them

 
• By Derrick Gingery

OND Director John Jenkins warns that new communications staff will not be equipped to deal with specific technical issues, but should be able to answer general questions.

New liaisons created for PDUFA V and intended to help improve sponsor-FDA communications only will be searching for answers to application questions, not giving them.

As part of the prescription drug user fee program renewal, FDA committed to create new communication positions in its drug and biologics centers to help sponsors get questions answered,

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More from North America

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