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RegisterEMA/USFDA: Inspections of BE studies [BE/BA News]
posted by Helmut 
– Vienna, Austria, 2013-12-25 18:28 (3768 d 18:37 ago) – Posting: # 12107
Views: 2,800
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.
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).
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.
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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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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- EMA/USFDA: Inspections of BE studiesHelmut 2013-12-25 17:28
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Ing. Helmut Schütz