EMA: Draft guideline on the conduct of efficacy studies for intramammary products for use in cattle

This revised guideline is intended to provide guidance on the conduct of efficacy studies and their evaluation for veterinary medicinal products that are administered via the teat canal to cattle. It therefore addresses the treatment of clinical and subclinical mastitis during the lactation period, the treatment of subclinical mastitis at drying off, and the prevention of new intramammary infections during the dry period. The scope of the guideline has been extended in order to include recommendations on preclinical data, in addition to those on clinical field studies for the demonstration of efficacy. Moreover, information is included for generic intramammary products.