By Kurt R. Karst – 2008 was a banner year for orphan drug designations. FDA’s Office of Orphan Products Development (“OOPD”), which, since September 2007, has been under the leadership of Timothy Coté, M.D., M.P.H., designated a record 165 products for orphan (i.e., rare) diseases …
By Kurt R. Karst – As a follow-up to our recent post on obtaining orphan drug designation and approval based on a major contribution to patient care – the so-called “MC-to-PC” orphan drug designation and approval – we thought we would post on another rarity …
By Kurt R. Karst – FDA’s recent approval of Antisoma Research Limited’s orphan drug, oral fludarabine phosphate, with 7 years of orphan drug exclusivity for the treatment of certain adult patients with B-cell chronic lymphocytic leukemia got us thinking about the unusual case of the …
