McDermott Will & Emery·FDA / LIFE SCIENCES REGULATORY
FDA Finalizes Prescription Drug Use-Related Software Guidance
FDA issued final guidance on October 20, 2026 on how it treats software tied to prescription drugs, closing out a September 2023 draft and giving pharma and digital-health teams a settled framework to test product plans against.
fda-guidanceprescription-drug-softwaredigital-healthdevice-regulationregulatory-consultation
Read the original firm alert → Wednesday, November 4, 2026