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Food and Drug Administration (FDA) › Healthcare › Investigations

Health Care Compliance Association (HCCA)

‘If Only She Could Have Been Stronger’: Miami Trial Fraud Leads to Prison, Personal Loss

Health Care Compliance Association (HCCA) on

In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more

Bass, Berry & Sims PLC

Research Using De-Identified Specimens: A Reminder from FDA

Bass, Berry & Sims PLC on

On October 18, the Food and Drug Administration (FDA) issued a letter reminding developers of in vitro diagnostics (IVDs) that institutional review board (IRB) approval is required before initiating a clinical investigation...more

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