Fabre-Kramer Pharmaceuticals' major depressive disorder (MDD) drug gepirone has been rejected by the FDA not once, not twice, but three times since the turn of the millennium.
The European Medicines Agency (EMA) will not accept the replacement of a pivotal clinical study that has been found to be non-compliant with good clinical practice (GCP) by another study during the assessment of a centralised marketing-authorisation application. This position, outlined in a paper published recently aims to reinforce the application of GCP during the conduct of clinical trials by applicants.
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