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UL Presents the India Pharma Regulatory & Compliance Summit 2014

The theme of the conference was ‘Sustaining Regulatory Compliance in the Pharma Industry.’ The summit offered an exclusive platform for the pharmaceutical sector that brought together prominent...

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False Claims Act: 2013 Patterns Set 2014 Trends

For Health Care companies, Fiscal Year 2013 was a year of record-setting fines and settlements under the False Claims Act. According to the US Department of Justice (DOJ), the government recovered $3.8...

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How are Quality & Compliance Teams Progressing Along the Quality-Based...

When we conducted our annual benchmarking study with clients in 2013, we learned just how far clients have advanced along the “Quality-based Learning Maturity Model” – I wanted to explain this model in...

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Investigator-Initiated Research: Responsibilities and Risks

Increasingly, Pharmaceutical and Medical Device companies are recognizing the value of investigator-initiated clinical research (IIR), also known as investigator-initiated trials (IIT). IITs serve an...

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FDA Enforcement and Business

In late January 2014, Assistant Attorney General Stuart F. Delery spoke at the CBI Pharmaceutical Compliance Conference, clearly identifying FDA’s expectations for the Life Science community and its...

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CDRH Updates the Case for Quality

In late February, Steven Silverman, Director of CDRH’s Office of Compliance, spoke before the Food and Drug Law Institute’s Medical Device Conference on Key Legal and Regulatory Requirements. Silverman...

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Drilling Into the FDA’s Combination Product Rule

When the US Food and Drug Administration (FDA) issued its final rule for current Good Manufacturing Practice (cGMP) Requirements for Combination Products, the rule was “… intended to promote the public...

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Global Regulatory Trends for Medical Devices

Countries from India to Canada, and from Russia to Japan, are intensifying their scrutiny of medical device development, manufacturing, importation and distribution. Until recently, medical devices...

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Top 5 Reasons Dietary Supplement Manufacturers are Embracing cGMP Training

I take six each morning, but my husband takes >10 and my kids take a bunch. How many dietary supplements (ok, call them vitamins or nutritionals) do you take each day? Sixty-eight percent of...

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DOJ’s Knox: Credit Will be Given for a Strong Compliance Program

I recently attended the Global MedTech Compliance Conference in Barcelona. This year’s joint AdvaMed/Eucomed event, which drew the largest attendance ever, was riveted by the words of DOJ’s Jeff Knox....

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