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Judge Blocks FDA on Marketing Claims Preemption

[ Price : $8.95]

Federal judge Charles Breyer says state claims about drug marketing practices are not preempted by FDA regulations.

FDA Accepts InSite NDA for Conjunctivitis

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FDA accepts for review an InSite Vision Inc. NDA for AzaSite, indicated for treating bacterial conjunctivitis.

First Community Drug Import Program Ending

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Springfield, MA, is planning to end its voluntary Canadian drug import program for city workers and retirees.

Comments Sought on Feed Mill Licensing

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Federal Register Notice: FDA seeks comments on the medicated feed mill licensing system.

FDA Looks to Ole Miss for Natural Products Research

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Federal Register Notice: FDA intends to receive an application for a single-source cooperative agreement for FY 2006 to the Univer...

FDA Clears Stryker Hip Bearing System

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FDA clears a Stryker Corp. 510(k) application for the LFIT Anatomic Femoral Heads with X3 Polyethylene liners, an advanced hip bea...

Utah Medical Wants Document Request Log

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Utah Medical CEO Kevin Cornwell wants to know who has been requesting disputed FDA inspection reports for his company.

Luitpold Expands Hydralazine Recall

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Concerned over the potential presence of particulate matter , Luitpold Pharmaceuticals expands an earlier recall of hydralazine HC...

Panel Recommends Radiesse Approval

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FDAs General and Plastic Surgery Devices Panel recommends approval of BioForm Medicals Radiesse for two soft tissue filler applica...

Troy Sees Plaintiffs Attorneys Moving to Other Compliance Issues

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Former FDA chief counsel Dan Troy says the agencys recent policy statement on preemption is forcing plaintiffs lawyers to begin lo...