Wyeth Packaging Problems Lead To Warning Letter, Triphasil-28 Recall
Executive Summary
Wyeth failed to adequately investigate cases of contamination involving a packaging extractable for two oral contraceptive drugs manufactured at the firm's Guayama, Puerto Rico facility, FDA states in a recent warning letter
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Biogeneric Bill Has “Reasonable Chance” In ’07 – Barr; More CEOs Unplugged
Barr optimistic about biogenerics in 2007: There is "a reasonable chance for passage" of follow-on biologics legislation in 2007, Barr CEO Bruce Downey says during Morgan Stanley CEOs Unplugged conference in New York Jan. 3. "I would suspect that with the change in the composition of the Congress that we will have hearings on that legislation both in the House and in the Senate," he adds, noting that he expects Rep. Henry Waxman (D-Calif.) to reintroduce follow-on protein legislation during the first two weeks of the new Congress, which was sworn in Jan. 4. Waxman, along with Sens. Chuck Schumer (D-N.Y.) and Hillary Rodham Clinton (D-N.Y.), introduced legislation in October that would grant FDA authority to approve comparable or interchangeable follow-on biologics (1"The Pink Sheet" Oct. 9, 2006, p. 5). If a bill is not passed in 2007, Downey said legislation is unlikely in 2008 due to the presidential election, but he "would certainly expect to see legislation by the end of 2009"...