Regulatory Affairs Professionals Society

Euro Roundup: EMA group recommends actions to accelerate regulatory science research

A European Medicines Agency (EMA) group has recommended actions the regulator and industry can take to accelerate regulatory ...
Regulatory Affairs Professionals Society

Euro Roundup: EMA finalizes reflection paper on biosimilar comparative efficacy studies

The European Medicines Agency has finalized its reflection paper on a tailored clinical approach to biosimilar development, ...
BusinessWorld

Regulatory agility key to faster access to life-saving medicines

Access to life-saving medicines often depends not only on scientific breakthroughs, but on how quickly and efficiently regulatory systems can evaluate and approve them.
ascopubs.org

The European Medicines Agency (EMEA) guideline on oncology drug development

Financial conflicts of interest amongst abstracts, speakers, and planning committee members at the American Society of Clinical Oncology Annual Meeting No significant financial relationships to ...
Healio

European Medicines Agency recommends Dupixent for adults with prurigo nodularis

Please provide your email address to receive an email when new articles are posted on . The European Medicines Agency has recommended the approval of Dupixent in the European Union for adults with ...
Reuters

European Medicines Agency

US, European regulators set principles for 'good AI practice' in drug development The U.S. Food and Drug Administration and the European Medicines Agency jointly issued principles for safe and ...
Reuters

US, European regulators set principles for 'good AI practice' in drug development

Jan 14 (Reuters) - The U.S. Food and Drug Administration and the European Medicines Agency jointly issued principles for safe and responsible use of artificial intelligence in developing medicines, ...