Pediatricians Upset OTC Cough/Cold Drug Label Revamp Off FDA's Radar

The American Academy of Pediatrics (AAP) is upset that FDA's effort to revise labeling for over-the-counter (OTC) cough and cold medications for children was scrapped from the agency's spring 2016 regulations agenda -- marking the first time the regulatory effort has been off the agency's agenda since 2008. FDA has been under pressure -- including from Congress -- for years to revise the monograph, with agency advisors concluding as early as 1976 that data on the products' use in children...

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