In the medical device industry, FDA inspections are not a regulatory hurdle — they are a powerful tool for improving product ...

In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many ...

AI agents can never be deployed to handle highly regulated processes. The lack of consistency and data security risks are too ...

As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, ...

It has been increasingly clear … the Trump administration’s disdain for the very people necessary to implement your agenda,’ ...

Maharashtra FDA to address regulatory gaps for strengthening compliance and quality: Shardul Nautiyal, Mumbai Wednesday, ...

While a pause on federal health agencies is nothing new during presidential transitions, the Trump Administration’s ...

Groups often at odds – such as Consumer Brands Assn. and Center for Science in the Public Interest – unite to protest Trump’s 89 terminations at the food safety agency.

Globus Medical Inc. (NYSE:GMED), a leading medical device company specializing in musculoskeletal disorders, has been making waves in the healthcare sector with its recent acquisition of Nevro Corp ...

In this digital era, Vamsi Upputuri, a leading expert in regulatory automation, explores cutting-edge advancements in ...

The "Mastering Pharmaceutical Document Management: Strategies for Compliance and Efficiency" training has been added to ResearchAndMarkets.com's offering. This specialized course offers a deep dive ...

Outset Medical (OM) announced it has been notified by the FDA that all issues cited in a warning letter the company received in July of 2023 ...