From: CDER DRUGINFO Sent: Monday, December 22, 2003 10:10 AM To: Dockets, FDA Subject: FW: FDA Comments -----Original Message----- From: dale.hawaii@usa.com [mailto:dale.hawaii@usa.com] Sent: Monday, December 22, 2003 1:35 AM To: druginfo@cder.fda.gov Subject: FDA Comments Name: Bonnie and Dale Dudas E-Mail: dale.hawaii@usa.com Comments: we cannot respond in time to your Dec 22nd deadline by mail, so we're letting you know we're in 100% agreement with the letter below. We would be happy to provide additional testimonial information. This letter was written to the FDA on 3 Dec 2003: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003D-0478] Draft Guidance on Marketed Unapproved Drugs; Compliance Policy Guide; Availability AGENCY Food and Drug Administration, HHS. ACTION Notice. To Whom This May Concern, Response to: 2003D-0478; Draft Guidance on Marketed Unapproved Drugs Compliance Policy Guide; Availability 10/20/03 12/22/03 (body of letter ommitted due to length) Yours sincerely, The International Guai-Support Group Network Kathleen Shuller Guai-Support Representative Panama City Fl Sincerely, Bonnie and Dale Dudas - Honolulu, HI