EyeGate Pharmaceuticals has addressed three of the four outstanding action items regarding an FDA investigational device exemption amendment filed for its ocular bandage gel, the company announced in a press release.
The FDA had requested clarification of previously submitted data, modifications to manufacturing process documentation and validation of a filter used in the sterilization process. EyeGate has provided clarification of questions on the data and documentation changes have been addressed, while the filter validation work continues, the release said.
“With this next step
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