Supplement Labeling Guide Set For Release This Year – FDA Guidance Agenda
This article was originally published in The Tan Sheet
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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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)...
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