Regulatory Blog

The U.S. Food and Drug Administration (FDA) has announced the release of " Over-the-Counter Monograph Drug User Fee Program-Facility Fee...

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released a final guidance titled "Providing...

Today (22 June 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research released a draft guidance on...

Yesterday USFDA published the fees for over-the-counter (OTC) monograph drugs for fiscal year (FY) 2022 in a Federal Register Notice...

US Food and Drug Administration (FDA) issued draft guidance discussing formal meetings between sponsors of over-the-counter (OTC)...