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One commenter indicated that they recently updated their MRF to meet the annual update requirement and it required 5 times the amount of hours CMS estimated for the annual burden estimates

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July 16 Product: Orexos OX124 Indication: Opioid overdose Second time is not the charm for Orexo, as the FDA denied its application for OX124, a high-dose naloxone nasal spray for the rescue treatment for opioid overdose