Regulatory Blog

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 (

Maintaining the safety of the blood supply is a critical public health priority, particularly during outbreaks of emerging infectious diseases. Ebola disease, caused by viruses of the Orthoebolavirus genus, is associated with severe illness and can be transmitted through direct contact with infected body fluids. Although transfusion-transmitted Ebola disease has not been widely documented, the potential risk of transmission through blood and blood components requires appropri

Determining whether a product qualifies as a medical device is one of the most important regulatory decisions for manufacturers before placing a product on the Great Britain market. Many products fall into a "borderline" category because they may share characteristics with medicines, cosmetics, food supplements, biocides, personal protective equipment (PPE), or other regulated products. To provide greater regulatory clarity, the Medicines and Healthcare products Regulatory Ag