FDA, EMA to Hold ‘One-on-One’ Talks on Orphan Drugs With Industry

The FDA and the European Medicines Agency (EMA) will hold a joint workshop this fall for drug- and devicemakers of orphan products to discuss both agencies’ rare disease programs. In addition to overview sessions on programs from both regulators, manufacturers will have the opportunity Oct. 4 to register for one-on-one meetings with FDA staff or EMA staff via video teleconference, to discuss specifics on applying for an orphan product grant or designation.
Drug Industry Daily