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MEETINGS / EVENTS

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May 05 - 07 2014, 12:00 AM - 12:00 AM

2014 ASA Legislative Conference

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FDA MEDWATCH ALERTS

April 18, 2014

Propofol Injectable Emulsion, USP by Hospira: Recall - Visible Particulates

Summary:

Propofol Injectable Emulsion USP by Hospira Recall Visible Particulates

April 18, 2014

FDA MedWatch - ARKON Anesthesia Delivery System with Version 2.0 Software by Spacelabs Healthcare: Class I Recall

Summary:

FDA MedWatch Class I Recall 4 18 14

March 28, 2014

FDA Update on the Shortage of Normal Saline

Summary:

FDA Update on the Shortage of Normal Saline

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ASA FEATURED PRODUCT

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Anesthesiology Continuing Education (ACE) Program

SKU: 30702-14CE

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Single Copies, Member Price: $360

FDA Releases New Actions on Drug Shortages, Recognizes ASA Efforts

Tuesday, November 05, 2013

The Food and Drug Administration (FDA) announced that it is taking two actions to enhance the Agency's ongoing efforts to address drug shortages. 

First, the FDA released a "Strategic Plan for Preventing and Mitigating Drug Shortages," which was required under Title X of the Food and Drug Administration Safety and Innovation Act (FDASIA).  In March 2013, ASA formally submitted recommendations to the FDA on the Strategic Plan.  The Strategic Plan recognizes ASA's ongoing work with the FDA on drug shortages and states that the FDA will "join with other stakeholder groups, such as groups convened by the American Society of Anesthesiologists…" to develop long-term prevention strategies on shortages. 

Second, the FDA issued a proposed rule requiring that manufacturers of certain drugs notify the FDA of a permanent discontinuance or a temporary interruption in manufacturing that is likely to disrupt supply.  This proposed rule implements the early notification requirements in FDASIA.  ASA actively lobbied to ensure that the early notification requirements applied to drugs used "during surgery" and in the "treatment of a debilitating disease or condition," which includes anesthesia and pain medications. 

ASA's advocacy, alongside other key stakeholders, resulted in passage of the drug shortage provisions in FDASIA.  In May 2012 at the ASA Legislative Conference "Lobbying Day," more than 500 anesthesiologists visited Capitol Hill urging support for drug shortage relief and highlighting the significant impact drug shortages have on the practice of anesthesia. 

Since the passage of FDASIA, ASA has continued to work closely with the FDA to address drug shortages. 

ASA is currently reviewing the Strategic Plan and the proposed rule.

Read the Strategic Plan.

Read the Proposed Rule.

Learn More About ASA's Advocacy on Drug Shortages.

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