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FDA Transparency Task Force Delves into Difficult Disclosures

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A second public meeting by FDAs Transparency Task Force examines difficult public disclosure opportunities involving NDA withdrawa...

FDA Clears Patient Monitoring System

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FDA clears an Alcatel-Lucent 510(k) for the Alcatel-Lucent TeleHealth Manager, a secure, remote patient monitoring system.

Dental Amalgam Dispute Rears its Head at Transparency Meeting

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Anti-dental amalgam advocates use the FDAs Transparency Task Force Meeting to air their frustration with the agencys handling of i...

Data on Zimmer Spines Dynesys Tainted by Payments?

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FDA reviewers tell an advisory committee that Zimmer Spines Dynesys Spinal System met its goals in treating non-fusion patients fo...

Pittsburgh Cancer Researcher Violated Study Regs: CBER

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CBER warns Pittsburgh cancer researcher Jack Kirkwood on violations in his role as clinical study sponsor or investigator with inv...

Suits Not Slowing FDAs Tobacco Work: Deyton

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FDA Center for Tobacco Products director Lawrence Deyton says that industry lawsuits challenging the new tobacco legislation are n...

FDA Cites Hopewell Compounding Violations

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FDA says that Hopewell Pharmacy and Compounding Center is compounding three strengths of sodium tetradecyl sulfate injection that ...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Hopewell Pharmacy and Compounding Center, Charles McKay MD, Perry Veterinary Cli...

Unomedical Recalls Some Manual Pulmonary Resuscitators

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FDA says that a Unomedical recall of specific manual pulmonary resuscitators due to a potential malfunction is a Class 1 recall.

FDA Clears PerkinElmer Newborn Screening System

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FDA clears a PerkinElmer 510(k) for the GSP Genetic Screening Processor, intended for use in newborn screening programs.