FDA Advanced Manufacturing Technologies Designation program (from Catapult's regulatory round-up for December 2024)

FDA has issued a final guidance for industry entitled “Advanced Manufacturing Technologies Designation Program.” This guidance provides recommendations to persons and organisations interested in participating in the program, which facilitates the development of drugs manufactured using Advanced Manufacturing Technologies (AMT) that has been designated as such under the program. Early adoption of AMTs by the pharmaceutical industry is encouraged by the FDA as it can improve the reliability an...