Regulatory issues for phage-based clinical products

Phage-based therapeutic products are members of a growing and diverse group of products categorised as 'biologics), 'biologicals' or 'biotechnological products'. They are regulated in much the same way as conventional drugs a lthough in America they have their own division at FDA, the Centre for Biol ogics Evaluation and Research, (CBER) las opposed to (CDER), the correspond ing drugs division). The distinction is important because there are signifi cant differences between the two divisions in the amount of toxicological c haracterisation, clinical testing and manufacturing data that must be submi tted for approval. Also, there are important differences in the extent to w hich multiparty manufacturing arrangements are permitted. There are a numbe r of regulatory issues surrounding phage-based clinical products that, if a ddressed early during product development, will not become blocks to progre ss later on. The regulatory issues arise in part because of the unique natu re of phage-based clinical products and in part because of their intended c linical use. (C) 2001 Society of Chemical Industry.