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February 3, 2020
CDER Outlines CGMPs — and Exemptions — for Outsourcing Facilities
CDER spelled out current good manufacturing practices for drug compounders that register as outsourcers in a new draft guidance — and noted when the FDA does not intend to take regulatory action.
January 31, 2020
CDER Outlines CGMPs — and Exemptions — for Outsourcing Facilities
The guidance reflects FDA’s intent to recognize the differences between outsourcing facilities and conventional drug manufacturers,” the agency said.
January 23, 2020
CDER Outlines CGMPs — and Exemptions — for Outsourcing Facilities
CDER spelled out current good manufacturing practices for drug compounders that register as outsourcers in a new draft guidance — and noted when the FDA does not intend to take regulatory action.