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i thank you for that kind introduction for the next topic weamp;#39;ll be discussing drug substance facilities in particular hidden facilities and critical intermediate facilities used in the manufacturing of drug substances again my name is cassandra avalard iamp;#39;m a consumer safety officer from the office of pharmaceutical manufacturing assessment my colleague way from the office of new drug products weamp;#39;ll give the second half of this presentation which focuses on critical intermediates as a reminder please type any questions in the q a box so we can answer these during the live q a following the presentations so when it comes to drug substance facilities often there is some confusion or lack of clarity on which facilities involved in manufacturing need to be listed in applications during this presentation weamp;#39;ll attempt to clarify which facility should be listed the following facilities in the dmf uh are recommended to be included on the nda and or a nda 356h fo
