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View Full Version : 03/16/05 FDA: Guidance for Science Based Disputes



Poster
03-16-2005, 03:59 PM
The FDA has submitted an ICR to OMB regarding the dispute resolution procedures for science-based decisions on products regulated by the Center for Veterinary Medicine (CVM). The FDA is issuing guidelines for resolving scientific based disputes. The final guidance recommends that applicants first seek review though the chain of command at CVM, then go to the Veterinary Medicine Advisory Committee. The expected ICR respondents will be applicants seeking approval of animal drugs or other products regulated by CVM who have a scientific dispute with FDA.

Docket No. 2003D-0167

For more information see: http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/pdf/05-5040.pdf