Swissmedic has published Version 21.0 of its Formal Requirements guidance document, introducing updates and clarifications relating to medicinal product authorisation applications, documentation requirements, biosimilars, Article 13 TPA submissions and combination products incorporating medical devices.

FDA has published draft guidance on Essential Drug Delivery Outputs (EDDOs) for drug delivery devices and combination products. Learn how the recommendations may impact design controls, verification, validation, and change management activities.