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Supplement Labeling Guide Set For Release This Year – FDA Guidance Agenda

This article was originally published in The Tan Sheet

Executive Summary

FDA has started preliminary work on a Food Registration Implementation guidance, which the agency said is scheduled to come out after the release of its final rule on facility registration

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FDA Guidances On Actual Use Studies, Switches Will Clarify Agency Processes

A guidance on conducting actual use trials for Rx-to-OTC switch candidates is under development, according to FDA Office of New Drugs Director John Jenkins, MD

FDA In Brief

NSA switch prospects: FDA is "working hard" on WellPoint's citizen petition to switch non-sedating antihistamines OTC, Office of the Chief Counsel General Attorney Seth Ray says during FDLI Annual Educational Conference in Washington, D.C. April 2. In response to a question about whether FDA is "actively considering" a forced switch of Aventis' Allegra and Pfizer's Zyrtec, Ray noted "I think that's a fair assumption." When asked about potential classes of Rx drugs FDA might look to switch OTC, CDER Deputy Director Steven Galson, MD, said "we really haven't identified any as [a] top priority that we're working on...there's nothing that we're about to launch and announce in this regard." FDA recently stated its intention to become more proactive in Rx-to-OTC switches (1"The Tan Sheet" Feb. 10, 2003, p. 3)...

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC


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