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Home » FDA Adds Device Scenarios to Final GMP Guidance for Combo Products
FDA Adds Device Scenarios to Final GMP Guidance for Combo Products
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The FDA finalized guidance on GMP requirements for combination product manufacturers, adding scenarios to clarify how to comply with certain device requirements.
The 59-page guidance — which covers GMP requirements for drug-drug, drug-device, drug-biologic and biologic-device combination products — is largely the same as the 2015 draft guidance, except for the addition of compliance examples for prefilled syringes, drug-coated mesh and drug-eluting stents.
When a manufacturer intends to apply for marketing approval for a prefilled syringe containing a previously approved drug product, the manufacturer must demonstrate compliance with both the drug GMPs and device quality system regulations, the guidance said. — Derek Major
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