The European Medicines Agency (EMA) has published a draft guideline for nonclinical safety testing for radiopharmaceuticals, the European Association of Nuclear Medicine (EANM) has announced.
According to the EANM, "this is a very important document specifying the requirements in particular related to toxicity testing in the translation process from the preclinical development to clinical trials," and the association is planning to provide an official comment to this draft.
The EANM is inviting feedback on the EMA document by 20 May. Feedback can be submitted to the following Radiopharmacy Committee representatives:
- Clemens Decristoforo: [email protected]
- Oliver Neels: [email protected].
