Neuropace Receives FDA Guidance On Pma Supplement For Indication Expansion Into Idiopathic Generalized Epilepsy
NPCE•FDA gives guidance on PMA supplement for epilepsy indication expansion
July 28 (Reuters) - Neuropace Inc NPCE.O:
- Neuropace receives FDA guidance on PMA supplement for indication expansion into idiopathic generalized epilepsy
- Neuropace said the FDA requests additional clinical evidence from the Nautilus trial for the PMA supplement
- Neuropace said it will submit a submission issue request and amend the PMA supplement
- Neuropace said the FDA notice indicates the PMA supplement for IGE is not approvable in its current form
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