There is a new FDA guidane (2013) for general use injectors (no syringe).
The guidance asks to choose one kind of drug implementing in-vivo atudy in order to prove the safety and the efficacy of the device. Has anybody faced the requirement of choosing such drug and implementing in vivo study? The problem is mainly the kind of drug to chose.
Thank you,
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Yoram Levy
General Manager
QSite
Binyamina
Israel
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