EU, U.S. regulators offer single orphan drug path

Regulators in Europe and the U.S. have joined together to create a common application form for developers seeking orphan drug status. By making it easier to file the regulators are hoping that they will spur more programs for drugs that treat a host of rare diseases. Between the U.S. and Europe there are more than 55 million people who suffer from more than 6,000 rare diseases. But small markets can translate into small profits, which often leave developers cold to any suggestions for new therapies. This rare cross-Atlantic alliance is aimed at making the field more attractive, while giving regulators a chance to gain from their common experiences.

- check out this release from the agencies

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