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U.S. Department of Health and Human Services

Drugs

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Medical Gas Regulation Review; Announcement of Public Meeting

On July 9, 2012, President Obama signed FDASIA (Public Law 112-144) into law. Section 1112(a) of FDASIA provides that not later than 18 months after its enactment, the Secretary, after obtaining input from medical gas manufacturers and any other interested members of the public, must determine whether any changes to the Federal drug regulations are necessary for medical gases and submit a report regarding any such changes to the Committee on Health, Education, Labor, and Pensions of the U.S. Senate and the Committee on Energy and Commerce of the U.S. House of Representatives. The Food and Drug Administration is holding a public meeting on December 6, 2013 to obtain feedback on whether any changes to the Federal drug regulations are necessary for medical gases as part of the implementation of FDASIA.

Date:           December 6, 2013

Time:           9:00 a.m. to 5:00 p.m.

Location:     FDA White Oak Campus
                      10903 New Hampshire Avenue,
                      Bldg. 31, Room 1503A (Great Room)
                      Silver Spring, Maryland 20993

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