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Medical food manufacturer premarket registration suggested by Mead Johnson.

This article was originally published in The Tan Sheet

Executive Summary

MEDICAL FOOD MANUFACTURER "REGISTRATION" WITH FDA as premarket notification suggested by Bristol- Myers Squibb's Mead Johnson Nutritional Group in Feb. 25 comments to the agency. "Although FDA does not have the statutory authority to require premarket notification" from medical food makers, "a registration requirement could help the agency identify the manufacturers of medical foods, their manufacturing locations and the products that are sold as medical foods," Mead Johnson states. The company submitted its comments in response to FDA's Nov. 29 advance notice of proposed rulemaking initiating a "re-evaluation" of the regs governing medical foods ("The Tan Sheet" Dec. 9, 1996, pp. 7-9).
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