FDA Guidance for Industry: Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products

Title:
FDA Guidance for Industry: Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products

https://www.gmp-compliance.org/files/guidemgr/essential_drug_delivery_outputs_for_devices_intended_to_deliver_drugs_and_biological_products_draft_guidance_june_2024_0.pdf

Origin/Publisher:

FDA

Content:
This guidance addresses key aspects of drug delivery performance information for devices, and combination products, that include device constituent parts, intended for delivery of a human drug, including a biological product (herein referred to as drug delivery devices).

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