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Latest News | 22 May 2012

NICE Fires Back at Study, Claims its Approval Times Are Steadily Falling

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The National Institute for Health and Clinical Excellence (NICE) is aggressively firing back at a study released which claimed the health technology assessment (HTA) body was taking an average of five [Read More...]

Tags: Approval Delay Dillon NICE OHE report
Latest News | 18 May 2012

GAO Finds FDA Employee Review Practices Lagging

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The Government Accountability Office (GAO), the government agency in charge of auditing federal programs, has reviewed the US Food and Drug Administration’s (FDA) and found its employee performance [Read More...]

Tags: Employees FDA GAO Improvements MDUFA PDUFA report Review
Latest News | 17 May 2012

Security Agency Warns About Medical Device Vulnerabilities

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The US Department of Homeland Security (DHS) issued a warning on 4 May regarding the potential for medical devices to be compromised by hackers, saying “health care entities need to take [the threat] [Read More...]

Tags: DHS FDA Hack Hacking Regulatory report Security Vulnerability Warning Wireless
Latest News | 15 May 2012

MHRA Working to ‘Quickly Implement’ Recommendations from Commission

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The UK’s Medicines and Healthcare product Regulatory Agency (MHRA) said it is moving to act on recommendations made by a Commission in the aftermath of a scandal involving breast implant products made [Read More...]

Tags: Breast Implant Howe Implant Improvement Keough Lansley MHRA NHS PIP report Review UK
Latest News | 14 May 2012

Report: ‘Dramatic’ Increase in Q1 Medical Device Recalls

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A new report tracking medical device recalls during the first quarter of 2012 shows a massive spike in medical device recalls, reversing a fourth quarter (Q4) 2011 trend of reduced recalls.Medical [Read More...]

Tags: drug ExpertRECALL Medical Device Pharmaceutical Quality Recall report Trends
Latest News | 14 May 2012

UK Publishes Review of PIP Breast Implant Scandal, Calls for Improvements

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The UK’s Department of Health (DOH) has released the result of a review into the Poly Implant Prothese (PIP) Scandal, finding the Medicines and Healthcare product Regulatory Agency (MHRA) to have [Read More...]

Tags: Breast Implant Howe Implant Improvement Keough Lansley MHRA NHS PIP report Review UK
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

Indian Parliamentary Report Says Clinical Trials Not Being Conducted Properly

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A scathing report from the Parliament of India’s Standing Committee on Health and Family Welfare (SCHFW) indicates pharmaceutical companies in the country are increasingly moving their clinical trials [Read More...]

Tags: Approval Clinical Trial Heterogeneous Homogeneous India Parliament Regulatory report Small Study
Latest News | 9 May 2012

Report: FDA Taking Longer to Approve Drugs With ‘Unmet Medical Needs’

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A new report published jointly by the California Healthcare Institute (CHI) and the Boston Consulting Group (BCG) is claiming the US Food and Drug Administration (FDA) is taking longer to approve [Read More...]

Tags: Approval Times BCG CHI CNS drug Drug Approvals FDA GI Oncology PDUFA Pharmaceutical Priority Review report time
Latest News | 9 May 2012

Scathing Parliamentary Report Blasts India’s Drug Regulatory Authority

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A parliamentary report authored by India’s Standing Committee on Health and Family Welfare (SCHFW) is blasting the country’s Central Drugs Standard Control Organisation (CDSCO), India’s drug [Read More...]

Tags: Blasts CDSCO DCGI India Parliament Regulatory report
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