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MEETINGS / EVENTS

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January 23 - 25 2015, 12:00 AM - 12:00 AM

ASA PRACTICE MANAGEMENT 2015

February 07 - 08 2015, 12:00 AM - 12:00 AM

ASA Certificate in Business Administration 2015

June 26 - 28 2015, 12:00 AM - 12:00 AM

Annual Perioperative Surgical Home Summit

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FDA MEDWATCH ALERTS

November 07, 2014

FDA MedWatch - Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator

Summary:

FDA MedWatch Nellcor Puritan Bennett 980 Ventilator System Class I Recall

October 25, 2014

FDA MedWatch - Intravia Containers by Baxter: Recall - Particulate Matter

Summary:

FDA MedWatch Intravia Containers by Baxter Recall

October 20, 2014

Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter

Summary:

FDA Medwatch Alert 10-20-14

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ASA FEATURED PRODUCT

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Self-Education and Evaluation (SEE) Program

SKU: 30701-14CE

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Single Copies, Member Price: $360

FDA Rejects Sugammadex Application

Monday, September 23, 2013

On September 23, Merck Inc. announced it had received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) informing the company that its resubmitted New Drug Application for sugammadex had been rejected.  According to Merck, the FDA raised issues with "operational aspects of a hypersensitivity study" that the FDA had requested in 2008. 

ASA had previously expressed strong support for the approval of sugammadex in a formal comment letter to the FDA's Anesthetic and Analgesic Drug Products Advisory Committee. The proposed indications for use of sugammadex are the routine reversal of moderate and deep neuromuscular blockade (NMB) induced by rocuronium or vecuronium, and the immediate reversal of NMB at 3 minutes after administration of rocuronium.

Review ASA's previous support.

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