Dears,
I want advise on a clinical trial which is classified as a BE with clinical endpoints in US and a Phase III study in EU. The intention is to submit an ANDA for approval. Please recommend if sample retention will be required to be followed in the EU countries?
Thank you
Nikita
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Best Regards,
Nikita Kathpal, MS
Regulatory Officer II, USA & Canada
Pharm-Olam International
450 N. Sam Houston Parkway, E. Suite 250
Houston, TX 77060
Email:
nikita.kathpal@pharm-olam.comDirect line: +1 713-559-7964
Main: +1 713-559-7900
Ext. 11164
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