1. In Vivo

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...

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?

More from Manufacturing Focus

More from In Vivo

Rising Leaders 2025: Namrata Saroj On The Importance Of Authenticity In Ophthalmology

 
• By Sushmita Panda

Namrata Saroj, chief business officer of Ocular Therapeutix, is highly respected in the retina community for her contributions to drug development. She talked to In Vivo about her journey in ophthalmology, leadership philosophy and the importance of authenticity in a close-knit specialty.

Johnson & Johnson MedTech: How To Scale Digital Solutions

 
• By Natasha Barrow

J&J's EMEA head of digital solutions, Julia Fishman, talks about the hurdles in scaling digital innovation and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.

Rising Leaders 2025: Emma Hodcroft On Taking Initiative When “Plan A” Falls Short

 
• By Anabel Costa-Ferreira

Emma Hodcroft, co-founder of Pathoplexus and a key Nextstrain contributor, stresses the importance of career flexibility for young scientists. She urges early-stage researchers to embrace curiosity, using her unconventional path as an example of how curiosity can lead to impactful success.