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January 8, 2014
If enforcement against pharmaceutical companies for off-label promotion by the Office of Inspector General (OIG) and the Department of Justice (DOJ) and the Food & Drug Administration (FDA) were not...
November 13, 2013
In the just issued Johnson & Johnson Corporate Integrity Agreement (CIA), the Office of Inspector General (OIG) has, for the second time in less than a year, required that a company maintain a...
September 18, 2013
Big pharma and their deep pockets have been the focus of enforcement activities for a number of years but in 2013 that tide may be turning. In the past few months, settlements with ISTA...
September 11, 2013
In what for some may be a relatively chaotic run-up to meeting California’s 2015 serialization regulation, it is critical for serialization project managers to assure implementation falls within the...
June 20, 2013
On May 24, 2013, the Department of Justice announced that ISTA Pharmaceuticals Inc., a subsidiary of Bausch+Lomb, pled guilty to felony charges of conspiracy to introduce a misbranded drug into...
March 12, 2013
Unexpected events often happen in the everyday world. However, in the regulated world great efforts are made to minimize the severity and frequency of unexpected events. Yet, despite best efforts,...
January 10, 2013
4 Key Parts to a Complete Product Complaint Handling ProgramAccording to 2012 FDA statistics, drug company’s Product Complaint handling systems (21 CFR 211.198) were cited in 142 Turbo EIR...
December 31, 2012
Blood Plasma, or simply plasma, is the liquid portion of blood. It has a number of vital functions in bleeding and infection control. It contains proteins and antibodies, which are produced by the...
October 25, 2012
The most recent FDA report (FY2010) said the third highest reason a 483, warning letter, or consent decree was issued was because of discrepancies and/or failures in investigations due to inadequate...