EMA news in brief
The EMA has released a concept paper on developing guidelines in using risk-based approaches when assessing advanced therapy medicinal products
The EMA has released a concept paper on developing guidelines in using risk-based approaches when assessing advanced therapy medicinal products;
It has released practical information during the early phase of an orphan drug market application;
And it has published a paper on revising its guidance on the quality, pre-clinical and clinical aspects of gene transfer medicines;
The agency has also released a guideline on clinical investigations into epilepsy medicines; and
It has released comments about a draft guideline on clinical investigations of medicines treating osteoarthritis.