Regulatory Blog

Myelodysplastic syndromes (MDS) are a group of complex, clonal blood disorders that predominantly affect older adults and may progress to...

On 07 January 2025, the U.S. Food and Drug Administration (FDA) released the draft guidance titled " Developing Drugs for Optical Imaging...

The International Council for Harmonisation (ICH) continues to advance global standards in drug development and clinical practices with...

The USFDA  continues to innovate its regulatory landscape with the release of three important guidance earlier today (27 November, 2024)...

Today (29 May 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics...

Recently the European Medicines Agency released an updated guidance on "Qualification of Novel Methodologies for Drug Development:...

The United States Food & Drug Administration released two draft guidelines today (18-May-2023) "Pediatric Drug Development: Regulatory...

Last week (19 April, 2023) the United States Food & Drug Administration released a new draft guidance on "Acute Radiation Syndrome:...

As part of its recent announcement, the International Council for Harmonization (ICH) released on 4 April 2022, a draft E11A guideline...