A key theme emerging from FDA complete response letters since 2018 is that data system validation is lacking in the ...

Despite shifts in key compliance frameworks and ongoing digitalisation across the entire pharmaceutical value chain, many organisations still rely on paper-based legacy systems and siloed compliance ...

Throne Science, an Austin startup whose AI-powered toilet camera launched to consumers just four months ago, has closed a $10 million Series A round — funding the one health-monitoring category that ...

Discover how New Approach Methodologies (NAMs) can play a role in food safety testing, producing more human-relevant results ...

YourStory presents the daily news roundup from the Indian startup ecosystem and beyond. Here's the roundup for Thursday, July ...

Spread the love“`html We live in a fascinating era, don’t we? Technology is advancing at warp speed, and it often feels like ...

High-level turnover has introduced uncertainty about how quickly the FDA’s agency-wide AI strategy will move forward.

After getting his hands on a rope driver module from the Apollo project era that had a big ‘Scrapped Module’ stamped on it, ...

Aidoc is bringing a system that can interpret images and make draft reports for radiologists to the FDA as the medtech ...

CISA updates software bill of materials guidance to clarify SBOM requirements for medical device makers under FDA rules effective Oct. 1, 2023.

The U.S. and Australian governments have released new guidance urging critical infrastructure organizations to prepare to ...

The FDA’s May 2026 guidance on cell and gene therapies provides for CMC flexibilities while insisting on quality and ...