United States

Pharmacovigilance in the United States is regulated by the U.S. Food and Drug Administration (FDA). Applicants and manufacturers must maintain records and submit post-marketing safety reports under the applicable product regulations, including 21 CFR § 314.80 for approved human drugs. Serious and unexpected adverse drug experiences from domestic or foreign sources must be submitted as 15-day Alert reports as soon as possible and no later than 15 calendar days after initial receipt; follow-up information must also be submitted within 15 days of receipt. Other reportable experiences are included in periodic reports, generally quarterly for the first three years after approval and annually thereafter unless FDA establishes a different schedule. Reports are submitted electronically through FDA's safety-reporting systems. U.S. rules do not use the EU QPPV or PSMF model, but companies must maintain controlled procedures, complete safety records, scientific review and inspection readiness. FDA may also require a Risk Evaluation and Mitigation Strategy (REMS) when additional measures are necessary to ensure benefits outweigh risks. FDA expressly uses the term Individual Case Safety Report (ICSR) and provides electronic submission routes and standards for expedited and non-expedited post-marketing ICSRs. Under 21 CFR § 314.80, non-expedited ICSRs are submitted with periodic adverse experience reports. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.