To do so, the Center for Drug Evaluation and Research (CDER) has established numerous initiatives, including the development of a research program to better understand the science of advanced manufacturing. The FDA has received significant funding from Congress for advanced manufacturing-related projects, and we continue to work with manufacturers looking to implement these new technologies to benefit even more patients. October 13, 2021: FDA’s Advanced Manufacturing Initiatives Helping to Provide Quality Human Drugs for Patients - FDA has long recognized the importance of advanced manufacturing. The guidance, which was prepared under the support of the International Council for Harmonisation (ICH), describes scientific and regulatory considerations for the development, implementation, and operation of continuous manufacturing. October 13, 2021: FDA announced the availability of a draft ICH guidance for industry titled Q13 Continuous Manufacturing of Drug Substances and Drug Products. November 10, 2021: Trust in the Time of Covid-19: 3D Printing and Additive Manufacturing (3DP/AM) as a Solution to Supply Chain Gaps - FDA and partners published a commentary in NEJM Catalyst Innovations in Care Delivery on how a public-private collaboration, Covid 3D TRUST, has helped to address critical supply shortages by empowering designers, manufacturers, and users of 3D-printed personal protective equipment (PPE) during the COVID-19 pandemic.

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