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...
View ArticleFalse 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...
View ArticleHow 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...
View ArticleInvestigator-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...
View ArticleFDA 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...
View ArticleCDRH 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...
View ArticleDrilling 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...
View ArticleGlobal 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...
View ArticleTop 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...
View ArticleDOJ’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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