Regulatory Blog

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

The European Medicines Agency (EMA) provides detailed guidance "Procedural Advice on Paediatric Applications" that aims to facilitate the...

The European Medicines Agency (EMA) yesterday(04 June 2024) updated and released the guidance document "Procedural Advice on Paediatric...

Developing drugs specifically for paediatric use comes with its own set of challenges, including ethical considerations, appropriate...

Recently on 09 June 2023, the European Medicines Agency released updated guidance on "Paediatric Submissions Via Syncplicity Web Client"....

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

Yesterday 07-September-2022, USFDA's Center for Drug Evaluation and Research published a draft guideline "General Clinical Pharmacology...

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

This guidance provides recommendations to holders of biologics license applications (BLAs) for specified biological products regarding...