Regulatory Blog

Medicines packaging, labelling, and Patient Information Leaflets (PILs) are essential components of medicine safety and regulatory compliance. They provide healthcare professionals and patients with critical information regarding the safe use, storage, administration, and identification of medicinal products. Throughout a medicine's lifecycle, these materials must remain accurate, up to date, and consistent with the approved product information to support patient safety and r

Next-generation sequencing (NGS) has become an essential tool in antiviral drug development, enabling detailed analysis of viral genetic changes and the identification of resistance-associated variants. Compared with traditional sequencing methods, NGS generates extensive sequence data that provides a deeper understanding of viral populations throughout clinical development. To promote consistent and high-quality regulatory submissions, the U.S. Food and Drug Administration (