TB CAB: Open letter to the European Medicines Agency
Open letter to the European Medicines Agency regarding the filing of the drugs delamanid and bedaquiline for market approval.
"We therefore urge the EMA both to be a pioneer in the TB regulatory field by approving new drugs if they are deemed safe and effective by the CHMP, and to be diligent in enforcing the required postmarketing studies that are conditions of approval."
