ARS Pharmaceuticals, Inc.
https://ars-pharma.com/
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Latest From ARS Pharmaceuticals, Inc.
Keeping Track: Return & Renewal At US FDA
Takeda’s TAK-721 is back, ARS Pharma will be back soon to appeal neffy complete response letter, US FDA’s Project Renewal brings Temodar labeling in current day, and more highlights from the Pink Sheet’s US FDA Performance Tracker.
Viatris Asks FDA Not To Approve Neffy Until Sponsor Conducts More PK/PD Studies
EpiPen maker says available evidence does not answer questions about how an intranasal epinephrine from ARS Pharmaceuticals will perform in a real-world anaphylaxis event. Viatris citizen petition argues issues raised at advisory committee were not resolved.
US FDA Looks To Assure Advisory Committees' Subject Expertise With More Temporary Members
Reform efforts in CDER include ensuring expertise is specific to the issues being discussed, which may mean more temporary voting members on advisory committees.
Expect More Temporary Members Voting In US FDA Advisory Committees
Reform efforts in CDER include ensuring expertise is specific to the issues being discussed, which may mean more temporary voting members on advisory committees.
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Pharmaceuticals
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Drug Delivery
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Drug Delivery
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