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U.S. Department of Health and Human Services

Drugs

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Over-The-Counter Drug Monograph System - Past, Present and Future; Public Hearing

The U.S. Food and Drug Administration is announcing a public hearing to obtain input on the Over-The-Counter (OTC) Drug Review. FDA would like input on how to improve the current OTC Monograph Process for reviewing certain nonprescription drugs. This public hearing is being held to obtain information and comments from the public on the strengths and weaknesses of the current OTC Monograph Process, the feasibility of potential modifications the Agency has identified, and ideas about other modifications or alternatives to this process.

Date:            March 25-26, 2014

Time:            9:00 a.m. to 4:00 p.m.

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

Registration to Attend the Workshop:

Register to attend or provide oral testimony at the meeting by submitting electronic requests to CDEROTCMONOGRAPH@fda.hhs.gov by March 12, 2014. Written or electronic comments to the docket has been extended until July 31, 2014.

Webcast Information

March 25

March 26