Tuesday, February 24, 2015 By Richard Smith As with many regulatory proceedings, a Food and Drug Administration hearing today will have effects reaching far beyond its official topic. An FDA scientific advisory panel is gathering to consider a new treatment for keratoconus, a rare but potentially disabling eye disorder. How the FDA responds could […]
Device Maker Slammed by Injured Patients at FDA Meeting
Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission. 2/24/2015 Avedro Inc. CEO David Muller was verbally battered by several injured LASIK patients during public presentations 2/24 at a joint meeting of two FDA advisory committees as he led his company’s efforts to win an approval recommendation for a new drug/device combination to treat eye disorders […]
Ex-FDAer Waxler to Oppose Avedro NDA at Advisory Cte.
By Jim Dickinson 02/18/2015 Former CDRH ophthalmic devices branch chief Morris Waxler will next week oppose an Avedro Inc. NDA seeking approval for riboflavin ophthalmic solutions with UVA irradiation for use in corneal collagen cross linking for the treatment of the conditions underlying progressive keratoconus or corneal ectasia following refractive surgery. The venue: the 2/24 […]