The subcutaneous (SC) route of administration using a device by the patient is increasingly being adopted for reasons of patient convenience and comfort. The regulatory pathway to approval for the conversion of a drug administered IV to one administered SC or the conversion of SC administration using a vial and syringe to administration using a prefilled syringe or autoinjector is complex and has evolved significantly over the past 10 years. A review of the rapid and consistent path to approval now enabled by regulators will be of value to the audience.
Learning Objectives:
Upon completion, participants will understand the clinical development pathway for subcutaneous drugs that were initially approved as IV formulations
Upon completion, participants will understand the clinical development pathway for autoinjector device approvals of drugs initially approved as subcutaneous formulation in a vial or given as a prefilled syringe
Upon completion, participants will understand the clinical development pathway for subcutaneous drugs approved using a different subcutaneous formulation form the originally approved drug
