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FDA Seeks Participants in Selecting Tobacco Panel Rep

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Federal Register Notice: FDA seeks any industry organizations interested in helping to select a nonvoting industry representative ...

Philadelphia District and SoCRA Plan Clinical Trial Workshop

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Federal Register Notice: FDA Philadelphia District and SoCRA plan a public workshop 10/21-22 entitled FDA Clinical Trial Requireme...

Nominations Sought for Tobacco Committee

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Federal Register Notice: FDA requests nominations for members to serve on the Tobacco Products Scientific Advisory Committee in th...

ISTA Pharmas Xibrom Achieves Positive Phase 3 Results

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ISTA Pharmaceuticals says preliminary results of a Phase 3 trial of Xibrom 0.9% once-daily showed that it had achieved the primary...

What FDA Single Campus? White Oaks Already Too Small

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Editor Jim Dickinson reviews dwindling prospects for FDA ever finding its long-dreamt single campus as the agency renews DC-area l...

Labeling Changes Include Psych. Effects in Smoking Cessation

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FDA announces safety-related labeling changes approved in July for 38 drugs, including new boxed warnings for smoking cessation dr...

Mylan v. Newspaper: Lay Media Cant Understand GMPs

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Consulting editor John Scharmann reviews the Mylan suit against the Pittsburgh Post-Gazette and concludes that lay-media investiga...

FDA Sets Tobacco Science Advisory Committee

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FDA establishes a Tobacco Products Scientific Advisory Committee and calls for nominations for committee members.

Aczone Letter Should Make Advertisers Cautious: Friede

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Attorney Arnold Friede says companies should be more cautious with drug advertising given the harsh approach taken by DDMAC in a r...

Complex Court Maneuvers Dont Stop Generic Eloxatin

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Attorney Kurt Karst says that Sanofi-Aventis complex legal maneuvers failed to stop FDA from approving ANDAs for generic Eloxatin....