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Saturday, September 16, 2017

"Gottlieb said he stood by the FDA’s interpretation of the law and that he expected no slowdown in terms of its enforcement."


"But he said the new guidance would help address concerns from smaller pharmacies that want to do just that but have resisted registering as outsourcing facilities because of the expense of regulatory compliance.
The draft guidance, he said, would allow smaller firms creating low-risk drugs to be subject to less onerous requirements than larger outsourcing facilities." read more here