FDA and EMA signal an opportunity to harmonize advanced therapy regulations
As regulators around the world prepare for an influx of new advanced therapy applications for cell and gene therapies (the Alliance for Regenerative Medicine predicts 10 to 20 applications annually by 2025), leaders at the FDA and EMA are now calling for more harmonization around their respective regulations.
Part of the problem is that many of these expensive therapies target orphan or ultra-orphan indications, which can create viability problems for developers. But entering multiple markets simultaneously may relieve some of those issues.
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