FDA recognizes World Rare Disease Day with policy announcement

In a decision that should help simplify and streamline the process for both regulators and sponsors of orphan drugs, the US Food and Drug Administration and the European Medicines Agency have agreed to accept the submission of one annual report on orphan drug designations. The move means that drug sponsors don’t need to duplicate their efforts to each regulatory agency, and it won't add any new requirements to the process.

The announcement arrives in recognition of World Rare Disease Day, February 28, as rare diseases are precisely the point of extending orphan drug status to drug makers.

Source: FDA