Zdrowie i gospodarka · 15/09/2022

FDA Releases Final Guidance for Elemental Impurities Q3D(R2)

The FDA has released a final guidance for industry on elemental impurities, revising the 2020 Q3D(R1) guidance to include permissible daily exposures for cutaneous and transcutaneous routes of administration, and providing risk assessment considerations for oral, parenteral, and inhalation routes.