Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to ...

We've all seen the various inspection labels at the grocery store and heard news about food recalls. But what's the actual ...

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...

As Associate Director of Regulatory Affairs at Micro Labs USA, Inc., he has developed strategies to reduce submission errors, speed up approvals, and strengthen DSCSA compliance. The Drug Supply ...

The ‘Generally Recognized As Safe’ process apparently would continue – if only for a while – but would require FDA ...

The investment of over $6 million will expand LGM Pharma’s Rosenberg, Texas manufacturing facility as part of its Phase I ...

The new rule goes into effect Feb. 25, 2025, with a compliance date in 2028 ... what manufacturers say on a package? The U.S. Food and Drug Administration is trying to help.

THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device ...

In a decisive push to enhance drug regulatory compliance, the Maharashtra Food and Drug Administration (FDA) is aggressively working to address critical manpower shortages. Of the 200 sanctioned drug ...

A California company's dried lily flowers have been recalled because they may contain undeclared sulfites, according to the U.S. Food and Drug Administration. The FDA and Hayward, California-based ...

Discover how outsourcing regulatory submission content development improves efficiency and ensures compliance.