EMA Urges Consideration of Patient Populations in Phthalate, Paraben Use

June 18, 2013
The European Medicines Agency May 8 published recommendations for drugmakers on the use of phthalates and parabens, urging consideration of patient populations. A draft guideline on phthalates, often used as excipients in oral drug formulations, tracks closely with final guidance on the subject issued by the U.S. Food and Drug Administration in December.
International Pharmaceutical Regulatory Monitor