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

New Approach Would Overcome Legacy Burden Of ‘Electronic Paper’

17 Dec 2018

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on In Vivo for daily insights

Start your 7-day free trial
Explore trusted news, analysis, and insights
Access comprehensive global coverage
Enjoy instant access – no credit card required

Start Free Trial

Already a subscriber?

Wide Of The Mark: ‘The Worst EU Medtech Predictions Have Not Come True’

19 Jun 2025

• By Ashley Yeo

Jana Grieb, European regulatory and market access legal expert at McDermott Will & Emery, explains why the healthtech and pharma industries are warming to the new EU health commissioner as he faces calls to make the MDR more “user friendly.”

This Belgian Biotech’s Drug Cocktail Could Help Reverse Muscle Aging

18 Jun 2025

• By Jo Shorthouse

While big pharma pours billions into creating new anti-aging molecules, a Belgian startup has taken a different path: combining existing safe drugs with AI precision. The early results suggest it might be onto something revolutionary.

Rising Leaders 2025: Doxie Jordan, From UNC Graduate To Global Market Strategist