FDAnews
www.fdanews.com/articles/158617-orphan-sponsors-to-get-one-on-one-talks-with-u-s-fda-ema-officials

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

September 13, 2013
The FDA and European Medicines Agency will hold a joint workshop this fall for makers of orphan drugs and medical devices to discuss both agencies’ rare disease programs. In addition to overview sessions by both regulators, manufacturers will have the opportunity on Oct. 4 to register for one-on-one video teleconferences with FDA and EMA staff to discuss the specifics of applying for an orphan product grant or designation.
International Pharmaceutical Regulatory Monitor