Reference Drug for EU Submission [Study Per­for­mance]

posted by auditor – India, 2012-02-08 11:15 (5253 d 16:24 ago) – Posting: # 8072
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Dear All,

Can any one tell me what is the procedure to get reference drug selection for Europe submission. is there any updated RLD list like US FDA.

With addition to this, is it mandate to conduct fasting and fed both study for EU submission?

Regards,

Auditor

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