Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
This marks significant growth since the approval of the first approved drug to be made via continuous manufacturing in July 2015, Vertex Pharmaceuticals’ cystic fibrosis drug Orkambi (lumacaftor/ivacaftor).
Fisher provided an update on FDA’s two advanced manufacturing programs, the Emerging Technologies Program (ETP) and its Advanced Manufacturing Technologies (AMT) designation program at the agency’s Regulatory Education for Industry (REdI) meeting on 20 May. He also discussed the differences between the ETP and AMT programs.
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