EMA Proposes Clarification to Anti-Cancer Drug Guidance Ambiguities

A European Medicines Agency committee proposed changes to clarify ambiguities in an international draft guideline for non-clinical studies of oncology drugs.

The guideline, developed by the International Council for Harmonisation, was made available for public comment by both the EMA and the FDA last year.

The EMA’s Pediatric Committee proposed a change in the wording of the guideline, noting that a section on the availability of clinical data from adults before initiating pediatric trials seemed to duplicate recommendations in other guidelines.