Reprinted with permission from fdaweb.com 10/05/2009 [Analysis by Jim Dickinson*] Forget “open government,” especially at FDA. As the Obama administration visibly wilts under national security objections to a reporter’s shield law and resists a federal judge’s order that it release an FBI interview with former vice president Dick Cheney about who “outed” secret agent Valerie […]

Posted 9/26/2009 www.regulations.gov Document ID: FDA-2008-N-0488-0024 September 14, 2009 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Comments of the National Research Center for Women & Families on “Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ Keratomileusis (LASIK) Devices; Establishing a Docket” [Docket No. FDA-2009-N-0488] The National […]

Posted 9/22/2009 FDA Hearing – April 25, 2008 Presentation of Todd Krouner, Esq. MR. KROUNER: Good morning again. I am here on behalf of Amanda Campbell. My name is Todd Krouner. I was recently retained by her. She is a widow now in Brentwood, Tennessee, whose husband, Lawrence Campbell, a police officer with that police […]

FDA Lasik Response to FDA Webview Challenged Reprinted with permission from fdaweb.com 09/14/2009 LASIK Surgery Watch says it disputes most of FDA’s response to FDA Webview in our publication of an interview with former FDA Division of Ophthalmic Devices Diagnostic and Surgical Devices Branch chief Morris Waxler, who said that FDA was mistaken in approving […]

Reprinted with permission from fdaweb.com CDRH to Review 18 ‘Violative’ LASIK Ads 09/11/2009 Responding to a complaint by Florida-based LASIK activist Dean Andrew Kantis, CDRH’s Office of Compliance said 9/11 it would give “appropriate review” to 18 Web site advertisements by LASIK surgery firms that Kantis had gathered and sent to office director Timothy A. […]

Former branch chief for diagnostic and surgical devices alleges the FDA caved under pressure from ophthalmologists to approve LASIK devices, despite high incidence of complications. Reprinted with permission from fdaweb.com On LASIK ‘We Screwed Up’ Says Ex-CDRH Review Leader 09/08/2009 When it first approved laser devices for LASIK indications in 1998, CDRH “screwed up” in […]

07-21-2009 The American Society of Cataract and Refractive Surgery (ASCRS) held its convention earlier this year in San Francisco.  At the convention LASIK surgeons performed skits making fun of damaged and suicidal LASIK patients. One skit poked fun at patients who complain of halos and glare after refractive surgery.  The skits were published on YouTube by Parag Majmudar.  One […]

Open Letter to Director Timothy Ulatowski Posted 7/13/2009 June 27, 2009 Timothy A. Ulatowski, Director Office of Compliance Food and Drug Administration Center for Devices and Radiological Health 9200 Corporate Blvd. Rockville, MD 20850 Dear Mr. Ulatowski, The recent FDA warning to consumers regarding Zicam cold products emphasized the seriousness of loss of smell and […]

Reprinted with permission from fdaweb.com 6/11/2009 Despite CDRH guidance limiting allowable medical device “complications” to 1%, it has approved lasers used in LASIK vision-correction surgery that exceeded a 20% complication rate in the clinical studies that supported their marketing applications. This is the basis of a 6/11 request by LASIK victim Lauranell H. Burch, who […]