Vocabulary Change: CDER Eliminating 'Review' For NDAs And BLAs
Like ANDA evaluations, US FDA plans to use the word assessment to describe them for NDAs and BLAs.
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All NMEs and original BLAs are expected to adhere to the team-based review approach by the end of the year, with expansion to other application types later.
OND will grow to eight offices and 27 clinical divisions, which is slightly different than an early proposal.
The FDA did not expect to meet many FY 2018 goals for on-time scheduling of formal PDUFA meetings or issuing written responses in lieu of meetings.