The FDA issued a safety communication earlier this month about amniotic fluid eye drops being improperly marketed for dry eye disease.
It's not clear if the companies made other changes to their products or their marketing following the FDA's earlier letters. The
"Your product is not the subject of an approved biologics license application , nor is there an IND in effect for your product," the FDA stated in both letters.getting tougher "The problem with such commercial activity is that such companies haven't tested their products in controlled clinical trials and the safety and efficacy of such amniotic fluid products in the treatment of individuals with dry eye disease and other diseases have not yet been established," Turner told MedPage Today. "These untested or inadequately tested products pose risks to patients, as the recent public safety notification issued by the FDA notes.
Paul Knoepfler, of the University of California Davis, who has also been tracking the stem cell industry, said that these products still could contain growth factors and other substances that could have activity in the eyes.
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