Onsolis fentanyl buccal soluble film regulatory update

BioDelivery said it and partner Meda expect an FDA response on a modified REMS program for pain drug Onsolis fentanyl buccal soluble film will be delayed until this summer. BioDelivery previously anticipated the FDA review would be completed already and is working with Meda and the agency on the few remaining components for final approval. In December, Meda submitted to the agency a modified REMS, which BioDelivery said would provide for potential broader access to Onsolis through retail pharmacies and reduce some of the administrative burdens placed on prescribers. ...