Orphan Drug Workshops Launched by the FDA

Sponsors will gain a tool to help develop orphan drug applications when the FDA begins its new series of two-day workshops in February. The FDA’s Office of Orphan Products Development will staff the workshops for drug and biologics makers and academic researchers, who will be expected to bring information for at least one specific product for a promising orphan drug for a rare disease, the FDA says in a notice.
Washington Drug Letter