Author name: emma.scrafton

Traditional methods for evaluating the immunotoxic potential of pharmaceuticals typically involve animal testing, which is time-consuming, costly, and raises ethical concerns. In response to these challenges, regulatory agencies, including the Food and Drug Administration (FDA), are actively encouraging the development and acceptance of alternative methods. FDA’s new guidance on dermal sensitisation The FDA has recently

Veterinary medicines are commonly used by veterinarians, farmers and pet owners to treat and prevent animal diseases. Like what is already in place for pharmaceutical products within ICH M7, a guideline is also available for veterinary medicinal products to ensure appropriate control of mutagenic impurities. The guideline provides a practical framework that is applicable to

New approach methodologies (NAMs) are non-animal methods – including in chemico/in vitro assays and in silico predictions – which are increasingly being used to assess the safety of cosmetic ingredients and products. A next generation risk assessment (NGRA) framework for skin sensitisation has recently been developed, and case studies highlighting the role of NAMs, defined