Animal & Veterinary
Draft Guidance Released on Dispute Resolution Procedures
FDA Veterinarian Newsletter July/August 2003 Volume XVIII, No 4
FDA has released a draft guidance for industry entitled “Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine (CVM).’’ This draft guidance document (Guidance Document #79) describes dispute resolution procedures by which sponsors, applicants, or manufacturers of FDA regulated products for animals may request review of science-based decisions. This draft guidance does not address procedures for handling issues associated with FDA’s new initiative to enhance pharmaceutical good manufacturing practices.
Draft guidance #79 is posted on the FDA/Center for Veterinary Medicine Home Page. Single copies of the draft guidance may be obtained by contacting the FDA Veterinarian.
Dr. Marcia Larkins, CVM’s Ombudsman says the document is significant because “it represents CVM’s compliance with the FDAMA requirement for a dispute resolution procedure in accordance with Section 562 of the Act. It updates, expands (and will replace) the current policy and procedure for formal appeals by giving stakeholders the additional option of requesting review by VMAC, and it includes the ombudsman function to facilitate the process.”
Written comments on the draft guidance may be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be submitted to http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. Comments should be identified with the full title of the draft guidance and Docket Number 03D-0167. Written comments on the draft guidance may be submitted at any time; however, comments should be submitted by August 4, 2003, to ensure their adequate consideration in preparation of the final document.
Additional information about this draft guidance may be found in the May 19, 2003, Federal Register and from Dr. Marcia Larkins, Center for Veterinary Medicine (HFV-7), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 301-827-4535, e-mail: email@example.com.