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CDSCO Panel Asks Akums for Detailed Data on Phase III Eye Drop Trial
['Parthika Patel', 'M. Pharm', 'Pharmaceutics']
Medical News, Health News Latest, Medical News Today - Medical Dialogues |
The panel, in its meeting held on August 26, 2025, at CDSCO headquarters in New Delhi, directed the company to provide subgroup analysis, justification for drug inclusion, and dosing rationale before further consideration.
The Phase III clinical trial report was presented in line with an earlier SEC recommendation dated March 23, 2023.
After detailed deliberation, the committee opined:The firm should provide detailed subgroup analysis for different multicenters and specific clinical conditions.
The firm should provide justification for the use of Moxifloxacin in all inflammatory conditions.
The firm should provide justification for using QID dose for both Nepafenac and Ketorolac.
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