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

The Goldilocks Isotope: Perspective Therapeutics’ ‘Just Right’ Alpha Radiotherapeutic

 
• By David Wild

Thijs Spoor's bet on lead-212 is paying off as Perspective Therapeutics advances three clinical programs with promising early efficacy signals and a comprehensive manufacturing strategy.

Unpacking The Impact Of Trump’s Tariffs On Drug Pricing And Production

 
• By Ed Silverman

Big pharma plans to invest billions of dollars in US manufacturing to avoid tariffs proposed by the Trump Administration. However, the implementation of these plans may be delayed due to regulatory complexities and rising costs from tariffs, potentially impacting drug prices for consumers.

RESILIENCE Initiative Navigates The World Of Making Medicines Through VR Technology

 
• By Anabel Costa-Ferreira

The process of manufacturing medicines can often be complex, expensive and harmful to the environment. Initiatives like RESILIENCE UK are seeking to simplify this process, utilizing VR technology to create a more sustainable learning environment for both students and companies.

Q&A: Rentschler’s CEO On The CDMO’s Pivot Away From Cell And Gene Therapy And More

 
• By David Wild

Rentschler Biopharma CEO Benedikt von Braunmühl tells In Vivo about the CDMO's strategic decision to exit the cell and gene therapy manufacturing space.

More from In Vivo

Deals Shaping The Industry, May 2025

 
• By In Vivo Team

An interactive look at pharma, medtech and diagnostics deals made during May 2025. Data courtesy of Biomedtracker.

Podcast: Flagship’s Vision To Predict And Prevent Illness, With Raj Panjabi

 
• By David Wild

Flagship Pioneering senior partner Raj Panjabi discusses shifting health care from reactive treatment to AI-powered prediction and prevention of disease before symptoms emerge.

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.