Patient Advocate Slams FDA Denial of LASIK PetitionLASIK patient advocate and former FDA LASIK advisory panel patient representative Paula Cofer has sharply criticized an eight-page FDA letter that denied a citizen petition submitted by former CDER branch chief Morris Waxler seeking the market withdrawal of approved LASIK excimer lasers and a public health advisory on their continued use.Writing to FDA Webview, Cofer says the letter states that “risks associated with each LASIK device are described in the patient labeling” (patient information booklet), yet in 2006 FDA removed from laser approvals the requirement for patients to be given the patient labeling …
2 Aug 2014 / howie209 / 0
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