FDA Commissioner Margaret Hamburg was asked if the fungal meningitis outbreak could have been prevented by FDA during a 4-hour hearing Nov. 14 headed by the chairman of the House Energy and Commerce oversight subcommittee. Her answer was that FDA had limited authority because the New England Compounding Center (NECC), Framingham, Mass., was a ?compounding pharmacy,? which is regulated by the state Board of Pharmacy.
FDA Issues Complete Response for High-Dose Opioid Rescue Med
July 16th 2024OX124 is a nasal spray provides rapid absorption of naloxone for patients experiencing an opioid overdose. The FDA would like to see additional technical data, as well as data on whether patients can correctly use the device.
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FDA Issues Complete Response for High-Dose Opioid Rescue Med
July 16th 2024OX124 is a nasal spray provides rapid absorption of naloxone for patients experiencing an opioid overdose. The FDA would like to see additional technical data, as well as data on whether patients can correctly use the device.
Read More
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