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 and robustness of the manufacturing process by:
- enhancing product quality
- reducing drug development time
- increasing or maintaining the supply of drugs
Published on the 9th of January 2025. Read the entire Regulatory Round-up – December 2024.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (12 février 2025). FDA Advanced Manufacturing Technologies Designation program (from Catapult’s regulatory round-up for December 2024). ELSIBI. Consulté le 7 octobre 2026 à l’adresse https://doi.org/10.58079/13ay3
