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SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

The glossary was originally published in 2014 and has been used to define excipient terms and acronyms commonly found in IPEC guides. This document supersedes the final guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued 02 October 2014. the “WeFun” product is an unapproved new drug).

FDA 52
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SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October

SQA

26 of 2014. Since health authorities have not yet published guidelines for a comprehensive control strategy specific to microbiological topics for ATMPs, it is up to the individual ATMP sponsor or license holder to apply these compendial references properly.

FDA 40