Helmut
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2013-12-25 18:28
(4554 d 05:23 ago)

Posting: # 12107
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 EMA/USFDA: Inspections of BE studies [BE/BA News]

Dear all,

on Dec 18th EMA and USFDA announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. :ok:
The 18 months pilot phase will start on January 2nd, 2014. For an overview see here.

The initiative is a follow-up on the collaboration on GCP-inspections started in 2009 (see here).

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