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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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.
Now most, if not all, assessment divisions within the Office of New Drugs have dealt with issues surrounding small trials and rare diseases, defying common belief that experience was spread unequally.