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Industry Roundup: FDA Inspecting McNeil Plants, Hi-Tech Gets Another Chance Against FTC

This article was originally published in The Tan Sheet

Executive Summary

J&J CFO Domnic Caruso says FDA officials are at McNeil’s three plants subject to a consent decree; an appeals court says a lower court should allow Hi-Tech to present additional evidence for weight loss claims.

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Hi-Tech Hunts Growth As FTC Picks Up Scent On Disputed Weight Loss Claims

FTC asks a federal court to re-instate a contempt order stemming from Hi-Tech Pharmaceuticals’ misleading claims for weight loss supplements that an appellate court overturned. Hi-Tech, meanwhile, argues for recusal of the judge who found the firm in contempt and ordered two executives to jail.

Hi-Tech Hunts Growth As FTC Picks Up Scent On Disputed Weight Loss Claims

FTC asks a federal court to re-instate a contempt order stemming from Hi-Tech Pharmaceuticals’ misleading claims for weight loss supplements that an appellate court overturned. Hi-Tech, meanwhile, argues for recusal of the judge who found the firm in contempt and ordered two executives to jail.

AER experiment gets OMB approval

A proposed experiment by FDA's Center for Drug Evaluation and Research designed to identify statements that most effectively convey OTC and Rx AER data to consumers has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995, FDA announces. The agency proposed the experiment, "Toll-Free Number for Consumer Reporting of Drug Product Side Effects: Comprehension" following a proposed rule in 2004 requiring all OTCs approved under an NDA or ANDA to add a toll-free number and other statement to product labeling for AER purposes (1"The Tan Sheet" April 26, 2004, p. 14)...

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