FDA – Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products Guidance for Industry and FDA Staff (Catapult’s regulatory round-up – July 2024)
This draft document provides guidance to industry and FDA staff on the purpose and content of a use-related risk analysis (URRA) and how a URRA, along with other information, can be used to determine human factors (HF) data needs during product development and to support a marketing application. This guidance applies to drug- and biologic-led combination products that include a device constituent part and are the subject of an investigational new drug application (IND), a new drug application (NDA), or a biologics license application (BLA) and supplements to these applications. Comments can be submitted until 9 September 2024.
Published on the 1st of August 2024 in Catapult’s regulatory round-up for July 2024.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (5 novembre 2024). FDA – Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products Guidance for Industry and FDA Staff (Catapult’s regulatory round-up – July 2024). ELSIBI. Consulté le 12 octobre 2026 à l’adresse https://doi.org/10.58079/12mjk
