Centre for Innovation in Regulatory Science

Analysis of clinical investigation (device) initial submissions received by the Medicines and Healthcare products Regulatory Agency between January 2022 and December 2025

Aims This study aimed to analyse clinical investigation‐device initial submissions received by the MHRA between January 2022 and December 2025. Methods Data on submissions were extracted from the clinical investigations unit data bank; software as medical devices were not include...

Characterization of Cry2Ab2 resistance in Crocidosema sp. (Lepidoptera: Tortricidae): resistance selection, inheritance, cross‐resistance patterns, and fitness costs

Abstract BACKGROUND The soybean bud borer, Crocidosema sp., evolved field resistance to Cry1Ac soybean in Brazil, raising concerns regarding the durability of Bacillus thuringiensis (Bt) soybean technologies and potential evolution of resistance to additional Bt proteins. Here, a...

Key challenges for in vitro testing of oral tobacco and nicotine products for regulatory applications: Recommendations for using in vitro toxicity and disease models

The Institute for In Vitro Sciences (IIVS) has sponsored a series of workshops with the aim of developing recommendations for scientific and technical approaches to conducting in vitro assays to assess potential toxicity within and across tobacco and nicotine products. As well as...