FDA Technologies Designation Program (from Catapult’s regulatory round-up – December 2023)

FDA encourages the early adoption of advanced manufacturing technologies (AMTs) that have the potential to benefit patients by improving manufacturing and supply dependability and optimizing development time of drug and biological products. AMTs can improve product quality through higher capability manufacturing designs and enhanced controls. This draft guidance provides recommendations to individuals and organizations interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program, which aims to facilitate the development of drugs, including biological products, manufactured using an AMT that has been designated as such under the program. Comments can be submitted until 12 of February 2024.

Published on the 5th of January 2024. Read the entire regulatory round-up for December 2023 here.