Retention samples [Regulatives / Guidelines]

posted by anky1212 – India, 2013-07-12 08:49 (4733 d 19:07 ago) – Posting: # 10972
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Dear All,

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.

i.e. retention samples to be retained + returned unused dispensed IPs to be retained and remaining unused IPs to be return to sponsor.

Kindly give your views for the same.

As per guideline, is it possible to return the IPs to sponsor??

Thank you.

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