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The regulatory agencies consider oversight as appropriately applied in direct proportion to the risk associated with a given product per se, independent of the technology employed in the manufacturing process. FDA cannot legally take socioeconomic considerations into ac-count in the premarket drug approval process; animal drugs must be evaluated on the basis of the objective criteria of safety and efficacy. However, FDA does not operate in a political vacuum and in a situation where heated political debates on the socioeconomic aspects of a new animal drug run concurrently with the regulatory evaluation of the drug, it is hard to believe that the agency would not be affected to some degree in its deliberations on the drug.
Agricultural biotechnology; animal biotechnology; bioethics; animal well-being; food safety; science communication; agricultural indistry; consumers sentimen;