FDA Lacks Transparency in LASIK Investigation

Reprinted with permission from www.fdaweb.com 05/25/2010 Oil Spill Has a Lesson for FDA: Federal Impotence [Analysis by Jim Dickinson*] Some sides see it as that old Washington blame game — the Gulf of Mexico oil spill is “Obama’s Katrina.” That may be so, but nevertheless, there is a sobering message for FDA in this disaster. […]

Former FDA LASIK Chief Calls Clinical Trial ‘Unethical’

Reprinted with permission from www.fdaweb.com 05/07/2010 Former CDRH chief of ophthalmic devices Morris Waxler, who was in charge of evaluation LASIK devices approved between 1996 and 2000, told the American Society of Cataract and Refractive Surgeons (ASCRS) 5/7 its proposed Phase 2 keratectasia trial on LASIK effects is unethical and “I will do everything I […]