Orphan Sponsors to Get One-on-One Talks With U.S. FDA, EMA Officials

The U.S. Food and Drug Administration and European Medicines Agency will hold a joint workshop this fall for developers of orphan medical products to discuss both agencies’ rare disease programs. In addition to overview sessions by each regulator, device- and drugmakers will have the opportunity on Oct. 4 to register for one-on-one video teleconferences with FDA and EMA staff. During those meetings, sponsors will be able to discuss specifics on applying for an orphan product grant or designation.
International Medical Device Regulatory Monitor