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FDA Looks To Strengthen, Speed Drug Reviews With Flow Of Quality Data

New Approach Would Overcome Legacy Burden Of ‘Electronic Paper’

 
• By Bowman Cox

Lift the burden of paper on drug quality reviews and the pace of innovation is no longer a problem for structural engineers or couriers – or even print or electronic document rooms. The focus at the US FDA is now on enabling direct transmission and analysis of critical quality data.

FDA Chemist Collage
Progress from paper, to e-paper, to data

Freed from the burden of paper reviews, the US Food and Drug Administration is plotting an escape from legacy free text that burdens electronic reviews with drug quality narratives.

As innovation accelerates, the time required to write and read these chemistry, manufacturing and controls narratives has become a luxury manufacturers and regulatory authorities can ill afford. Too often, the...

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