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Glossary

Periodic Summary Reporting

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Alternative reporting regime that is agreed between the manufacturer and the National Competent Authority for reporting similar incidents with the same device or device type in a consolidated way where the root cause is known or an FSCA has been implemented. 

Other glossary definitions

F

Fecal Microbiota Transplant (FMT)

Administration of fecal matter from a donor into the intestinal tract of a recipient in…

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C

Chemistry, Manufacturing, and Control (CMC)

A critical aspect of pharmaceutical development processes and applications. CMC includes bulk drug substance chemical…

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