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Latest News | 16 May 2012

Republicans Ramp up Pressure on White House Over PPACA Negotiations

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Republican members of the House Energy and Commerce (E&C) Committee announced in a 16 May statement they have obtained new information regarding the role of the White House in the 2009-10 negotiations [Read More...]

Tags: ACA Energy and Commerce Committee Investigation PhRMA PPACA Republicans
Latest News | 11 May 2012

As India Moves to Investigate Claims of Collusion, US Could Increase Scrutiny

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Fallout from a report by the Indian Parliament alleging widespread collusion and ineffectiveness at India’s Central Drugs Standard Control Organization (CDSCO) continues, as the Indian government has [Read More...]

Tags: Blasts CDSCO DCGI DOJ India Investigation Parliament Regulatory report Scrutiny
Latest News | 10 May 2012

Senators Launch Investigation Into ‘Dubious Marketing Practices’ of Pain Pill Manufacturers

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Explosive allegations have emerged from two prominent Senators regarding marketing tactics used by a number of pharmaceutical companies, including Purdue Pharma, Endo Pharmaceuticals and Johnson & [Read More...]

Tags: American Pain Foundation Baucus Collusion Congress drug Endo Pharmaceuticals Grassley Investigation J&J Johnson & Johnson Letter Pain Pain Pharmaceutical Purdue Pharma Senate
Latest News | 26 April 2012

FDA Getting New Director of Office of Criminal Investigations

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The US Food and Drug Administration (FDA) is getting a new Director of its Office of Criminal Investigations (OCI), reports Main Justice.John Roth, a 25-year veteran of the Department of Justice and [Read More...]

Tags: Director DOJ FDA Investigation OCI Roth
Latest News | 7 March 2012

FDA Asked To Explain Email Monitoring Policies

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Senator Chuck Grassley (R-IA) andRepresentative Darrell Issa (R-CA) sent a letter to the US Food and DrugAdministration (FDA) about their monitoring of nine employees who worked forthe agency. The [Read More...]

Tags: CDRH FDA FDA Nine Grassley Investigation Issa Letter Monitoring OMB OSC Surveillance Zients
Latest News | 24 February 2012

Ability to Clean Devices Emerges as a Safety Issue

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An investigative report by the The Center for Public Integrity (CPI) has found that medical devices that are difficult—or impossible—to clean properly are increasingly behind adverse events.“FDA has [Read More...]

Tags: Dirty FDA Investigation Medical Device report Sterilization Unclean
Latest News | 16 February 2012

Investigation into FDA Handling of Whistleblowers Widens

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The US Office of Special Counsel (OSC) announced on 15 February that it had opened an investigation into the US Food and Drug Administration’s (FDA) handling of whistleblower complaints made by [Read More...]

Tags: Congress FDA FDA Nine Grassley House Investigation Issa Office of Special Counsel OSC Senate Whistleblower
Latest News | 3 February 2012

EC Investigation of PIP Implants Inconclusive, Calls for Further Study

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A European Commission (EC) study of the breast implant products manufactured by French company Poly Implant Prothese (PIP) has come to inconclusive results regarding the rupture rate of PIP’s breast [Read More...]

Tags: Breast Implant EC European Commission France French Investigation PIP Poly Implant Prothese report Scandal Study
Latest News | 3 February 2012

Reuters: French Regulatory Authority, Executives Searched In Mediator Probe

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The offices of French regulatory authority Afssaps were searched by French investigators on 2 February as part of an investigation in to deaths associated with Servier’s anti-diabetes drug Mediator, [Read More...]

Tags: Adverse Event AFSSAPS Cardiovascular Deaths France French Investigation Mediator Searched Servier
Latest News | 1 February 2012

GAO: FDA Enforcement of Up-To-Date Information on Antibiotic Drug Labels Lacking

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An investigation by the US Government Accountability Office (GAO) has found that the US Food and Drug Administration (FDA) “has not taken sufficient steps to ensure that antibiotic labels contain [Read More...]

Tags: Accountability Antibiotic Breakpoint FDA GAO Investigation