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Vocabulary Change: CDER Eliminating 'Review' For NDAs And BLAs

 
• By Derrick Gingery

Like ANDA evaluations, US FDA plans to use the word assessment to describe them for NDAs and BLAs.

Scrabble Pieces
A review by any other name would smell as sweet.

Janet Woodcock continues to purge the word review from the Center for Drug Evaluation and Research, favoring the word assessment to characterize the new drug application clearance process.

After formally changing ANDA reviews to assessments about a year ago, Woodcock said NDAs and BLAs now also will undergo a similar evolution

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