Pharmacovigilance

Under federal law, distributors, manufacturers, and packers of drugs and dietary supplements in the United States must report medical problems associated with their products. Firms are required to document and assess adverse events based on “reasonable medical judgment.” Adverse events meeting the FDA defined criteria for serious must be reported to the FDA within 15 business days for dietary supplements/over-the-counter drugs without a new drug application, or within 15 calendar days for drugs possessing a new drug application if the serious adverse event is unexpected.

Serious Adverse Events may include, but are not limited to, the following: “death,” “a life-threatening experience,” “inpatient hospitalization,” “a persistent or significant disability or incapacity,” “a congenial anomaly or birth defect,” or “other serious (important medical events).”

All adverse events are documented and stored in our case management software application. Applicable individual case safety reports are submitted through the FDA electronic submissions gateway on behalf of clients or regulatory reports are provided to the clients for processing. Clients have access to their incident data 24/7 utilizing a secured password protected login interface.