When a regulator loses its way
This article was originally published in Clinica
The FDA has admitted to failings in its review of ReGen’s Menaflex device and conceded that its device approval processes need to be better protected against outside pressures. It also admits that it should have an “appropriately staffed component” to handle disputes with companies (see FDA admits fallibility over approval process, chaotic scenes at agency recounted, clinica.co.uk, September 28).
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