Pharma 101 - Pharmaceutical Fraud
Archive for July, 2007
CRO’s Conflict of Interest
St. Petersburg Reporter Chris Hundley wrote (July 1, 2007) a well-written, balanced and comprehensive (as can get in an article) about Contract Research Organizations (CRO’s). The article points out the inherent conflict of interest for CRO’s to manage clinical trials pre-approval (for NDA submission) and at the same time substantially invest in the pharmaceutical company that is the owner of the drug in trials. Although the FDA is quoted as not seeing the conflict of interest as a problem, and indicating that only 1-2% of inspections of clinical trials uncover fraud, it seems unlikely that the FDA is out looking for such fraud, or has enough resources to police the issue adequately. To read the complete article; to read more about pharmaceutical fraud.
| Posted By Marcella Auerbach | Responces 0 |
| Category Legal | Posted July 2nd, 2007 |
Regulatory Documents (PDF)
- OIG Compliance Program Guidance for Pharmaceutical Manufacturers
- Medicaid Rebate Applicability of Physician Administered Drugs
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