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 ...

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

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

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 ...

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

“The delay should not alter the impact, as full compliance is still years away,” he said. “This is a big win for consumers. The FDA is finally identifying healthy foods based on nourishing ...

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

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

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.