More than a decade after proposing to add emergency first-aid eyewash drugs to the OTC monograph for ophthalmic products, FDA will convene a public meeting to collect additional information on the eyewash category. The agency announced a public hearing to be held Dec. 4, 2013, at its White Oak headquarters in Silver Spring, Md., to obtain input from industry, medical experts and consumers about the formulation, manufacturing and labeling of OTC eyewash drugs. Some eyewash products are ready-to-use in small-volume containers, while others are concentrated solutions in large volumes that must be mixed with water, FDA says in a Sept. 18 Federal Register notice. The 2003 proposed rule for OTC eyewash solutions offered standards for minimum container volume and pH levels ([A#05110080007]).
The acting director of FDA’s Center for Drug Evaluation and Research’s Office of Pharmaceutical Science, 18-year agency veteran Keith Webber, will serve as Perrigo Co. PLC’s head of regulatory...
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