Drugs

Medication Errors Related to IND Labels Discussed

A 5/18-5/19 public meeting on potential medication error risks with IND drug container labels gathered information from national and international stakeholders for FDA to consider and determine if regulations are needed. The meeting was sponsored by FDA and the Reagan-Udall Foundation for FDA.

CDER Office of Surveillance and Epidemiology director Gerald Del Pan said that medication error risks may threaten the integrity of clinical investigations and affect the safety and protection of investigation subjects. “FDA has received medication error reports associated with investigational drugs,” he said. “These reports have included things such as wrong drug and wrong dose errors, some of which have resulted in serious adverse events. However, the incidence and nature of medication errors associated with investigational drugs is largely unknown. But published literature has pointed to the investigational drug container as a contributing factor for medication errors.”

Del Pan said the agency wanted to hear about the prevalence and nature of medication errors and practices that minimize the potential for medication errors, especially those errors that may result in serious adverse events or threaten the integrity of clinical investigations.

Download a transcript from the first day here and the second day here.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome