BIO Survey Seeks To Uncover Inconsistencies In Review Divisions
This article was originally published in The Pink Sheet Daily
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.
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Attorneys Sasinowski and Varond write that in some cases weak clinical evidence on the surrogate endpoint was not a barrier, but strong findings on unmet need and rarity usually are necessary for accelerated approval.
Members will enter data into secure database, allowing trade groups to gauge trends and problems with the PDUFA V application review program – and giving industry a stronger negotiating position for the next user fee round.
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.