Post by bot on Oct 31, 2013 17:55:18 GMT -5
FDA takes two important actions on drug shortages
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
--------------------------------------------------------------------------------
The U.S. Food and Drug Administration is taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages, a significant public health threat that can delay, and in some cases even deny, critical care for patients. Following the President’s 2011 Executive Order on reducing drug shortages, the number of new shortages in 2012 was 117, down from 251 in 2011.
Today’s announcements build on this work. First, the FDA is releasing a strategic plan called for in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to improve the agency’s response to imminent or existing shortages, and for longer term approaches for addressing the underlying causes of drug shortages. The plan also highlights opportunities for drug manufacturers and others to prevent drug shortages by promoting and sustaining quality manufacturing.
Second, the FDA issued a proposed rule requiring all manufacturers of certain medically important prescription drugs to notify the FDA of a permanent discontinuance or a temporary interruption of manufacturing likely to disrupt their supply. The rule also extends this requirement to manufacturers of medically important biologic products. The proposed rule implements the expanded early notification requirements included in FDASIA.
For more information, please visit:
FDA actions on drug shortages
1.usa.gov/16OQEO4?source=govdelivery&utm_medium=email&utm_source=govdelivery
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
--------------------------------------------------------------------------------
The U.S. Food and Drug Administration is taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages, a significant public health threat that can delay, and in some cases even deny, critical care for patients. Following the President’s 2011 Executive Order on reducing drug shortages, the number of new shortages in 2012 was 117, down from 251 in 2011.
Today’s announcements build on this work. First, the FDA is releasing a strategic plan called for in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to improve the agency’s response to imminent or existing shortages, and for longer term approaches for addressing the underlying causes of drug shortages. The plan also highlights opportunities for drug manufacturers and others to prevent drug shortages by promoting and sustaining quality manufacturing.
Second, the FDA issued a proposed rule requiring all manufacturers of certain medically important prescription drugs to notify the FDA of a permanent discontinuance or a temporary interruption of manufacturing likely to disrupt their supply. The rule also extends this requirement to manufacturers of medically important biologic products. The proposed rule implements the expanded early notification requirements included in FDASIA.
For more information, please visit:
FDA actions on drug shortages
1.usa.gov/16OQEO4?source=govdelivery&utm_medium=email&utm_source=govdelivery