Study acceptance by US Regulatory [Regulatives / Guidelines]

posted by balakotu – India, 2013-06-19 16:36 (4758 d 14:19 ago) – Posting: # 10819
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Dear All,

Please clarify regulatory acceptance by US-FDA for a study conducted for Europe region. The reference product is manufatcured in the same facility for both US & Europe and being marketed by the same brand name in both the regulatory regions.

Regards
Kotu

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