The European Medicines Agency is taking a hard look at whether patients taking inhaled corticosteroids for chronic obstructive pulmonary disease are at higher risk for pneumonia. [Read more…]
European Medicines Agency Advises Gene Therapy Developers on Regulatory Requirements
The European Medicines Agency (EMA) has issued draft guidance describing the types of evidence developers of gene therapies need to support marketing authorization — saying very small firms, which comprise the majority of this segment, may not be familiar with the regulatory process. [Read more…]