PDUFA V: Emerging Sponsor Communication Issue Resolved And Expanded
FDA and industry plan to create more staff to help deal with simple and clarifying questions from emerging and experienced sponsors during the application review process as part of PDUFA V.
You may also be interested in...
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.
TB Regimen Could Pave Way For More FDA Involvement In Neglected Tropical Diseases
TB Alliance plans to seek FDA approval for its treatment regimen, which is beginning a Phase IIb trial, as the agency looks to respond to calls for a clearer and quicker pathway for NTD drugs.
Tropical Disease Development Partnerships Want More Help From U.S. FDA
The agency’s infrastructure is not attracting many of the Product Development Partnership sponsors, Aeras official says, but new draft guidance could help.