Retention samples [Regulatives / Guidelines]

posted by jag009  – NJ, 2013-07-14 23:04 (4732 d 05:52 ago) – Posting: # 10973
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(edited on 2013-07-15 16:41)

❝ We had conducted one BABE study for USFDA regulatory.


❝ Sponsor had provided sufficient samples including retention samples. After sending of samples, sponsor had requested to return remaining IPs above retention sample quantity (Except returned unused IPs once study is completed.


The sponsor intends to submit the study? If not then he can have them all back, I.e., failed study. I used to ask for products to be return later if the study fails. Why? The clinic charges us for sample disposal after a while.

John

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