EMA Launches Review Of Panexcell Data

European Agency Investigates Concerns Over Marketing Authorization Studies

The European Medicines Agency is investigating concerns raised over data produced by studies from Panexcell Clinical Laboratories used to support European marketing authorizations.

Question_Marks
Questions have been raised over data from Panexcell • Source: Shutterstock

A review has been launched by the European Medicines Agency of medicines for which supporting studies were conducted by contract research organization Panexcell Clinical Laboratories at its site in Mumbai, India.

The review procedure – which the EMA noted was made under Article 31 of Directive 2001/83/EC, relating to non-centrally authorized...

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