Woodcock: single FDA center for rare diseases could be 'negative' to rare disease cause

FDA's Center for Drug Evaluation and Research (CDER) Director Janet Woodcock advised against a single FDA Center of Excellence (COE) for rare diseases. Woodcock made the remarks while speaking at the EveryLife Foundation for Rare Diseases scientific workshop on Thursday in Washington.

Her comments come after Hyman, Phelps & McNamara's Frank Sasinowski and James Valentine proposed creating a Rare Disease COE for greater consistency and efficiency in regulatory review of rare disease products (see "Proposal Seeks FDA Center for Rare Diseases")...