The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors of drug-device combination products in developing “essential drug delivery outputs” (EDDOs) that deliver consistent performance.
Products that are within the scope of this guidance include syringes, injectors, infusion products, nasal sprays, inhalers, nebulizers, and vaginal delivery systems. Information about the delivery devices must be submitted in the corresponding investigational or marketing application for combination products that rely on a delivery device…
