News

Latest News | 19 June 2013

FDA Wants Input on Quality Inspection, Import Procedures Under FDASIA

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When US legislators and President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law in July 2012, they did so – among other reasons – in the hope that Read More...

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Latest News | 17 June 2013

Global Networks Lead to Global Scandal as MHRA Defends Against Questionable Ranbaxy Practices

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For years, regulators around the globe have been touting the challenges and benefits of globalization, explaining that a globally diverse product supply chain means needing to rely on regulatory Read More...

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Latest News | 14 May 2013

Mexico, Turkey Petition to Join International Pharmaceutical Regulatory Group

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The Pharmaceutical Inspection Convention and Cooperation Scheme (PIC/S), an international forum for the exchange of regulatory information about pharmaceutical products, may soon see itself with two Read More...

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Latest News | 13 May 2013

Device Inspections, Deficiencies Skyrocket for Device Firms Since 2008

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The US Food and Drug Administration (FDA) may still be in the midst of figuring out how to overhaul its medical device compliance approach in regards to quality, but a new report out from device Read More...

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Latest News | 25 February 2013

Hamburg: Quality one of FDA's 'Highest Priorities' in 2013, Agency Creating New Quality Office

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In a wide-ranging speech before the Generic Pharmaceutical Association's annual meeting in Florida, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said her regulatory agency will Read More...

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Latest News | 25 February 2013

EMA Regulators Release ICH Guideline on Genotoxic, Carcinogenic Starting Materials

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EU regulators have released for public consultation a guideline under development by the International Conference on Harmonisation (ICH) intended to establish the best practices for controlling Read More...

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Latest News | 19 February 2013

How a Private Anti-Counterfeiting Initiative Could Pressure Regulators to Improve Drug Quality

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What happens when your local regulatory agency isn't known as being reliable or capable at overseeing the safety and quality of products in your country? In at least one country, consumers could soon Read More...

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Latest News | 11 February 2013

Quality Concerns Lead to Suspension of all Products Manufactured by Canadian Company

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Canadian regulators have announced the suspension of all medical device licenses issued to or otherwise associated with one medical device manufacturer after being made aware of "concerns about the Read More...

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Latest News | 7 February 2013

ICH Manufacturing Impurities Guideline Goes to FDA, EMA, MHLW for Consideration

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The International Conference on Harmonisation (ICH), the international pharmaceutical regulatory harmonization body, has released a draft guidance on the best practices for controlling carcinogenic Read More...

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Latest News | 5 February 2013

Massachusetts Regulators Discover Widespread Failings at Sterile Manufacturing Sites

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Crises are rarely ones of regulators' own choosing. So in 2012 when pharmaceutical compounding became the topic de jure after a massive outbreak of fungal meningitis, state and federal regulators Read More...

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