Regulatory Blog

The U.S. Food and Drug Administration (FDA) has announced On 30 July 2025 , the official user fee rates across its major healthcare...

In the evolving regulatory landscape of generic drug manufacturing, compliance and transparency  are more crucial than ever. The FDA’s...

The FDA Center for Drug Evaluation and Research, along with the FDA Center for Biologics Evaluation and Research, issued a revised draft...

This Monday (01 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics...

The User Fee programs help the Food and Drug Administration (FDA) to fulfill its mission of protecting public health and accelerating...