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Considerations for a Decentralized Manufacturing Paradigm

ISPE

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms.” FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” Journal of Biotechnology 213 (2015):120–30. doi:10.1016/j.jbiotec.2015.06.388

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Enabling Global Pharma Innovation: Delivering for Patients

ISPE

USA The FDA established the Emerging Technology Program (ETP) in 2014 and has actively promoted the program 8. www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/emerging-technology-program 9 US Food and Drug Administration Center for Drug Evaluation and Research. 22 June 2023. 22 June 2023. EMA/321483/2020. 3 July 2020.

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