PDUFA V: Communications Liaisons Will Help Find Answers, Not Give Them
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.
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The trade group will ask members to characterize their pre-clinical and clinical stage interactions with FDA in an effort to find potential efficiencies as well as inform upcoming legislation, including PDUFA VI.
Company Chief Medical Officer Kunkel says FDA has talked about manufacturing and trial design for its breakthrough designee much earlier than would be expected with a typical application.
Twenty sponsors now have applications in the new review model, but none have reached the approval decision stage; industry officials say it still is too early to draw conclusions.