Civil Money Penalties: Biologics, Drugs, and Medical Devices

Resumen

The Food and Drug Administration (FDA) is issuing final regulations to establish hearing procedures for use when FDA proposes the imposition of administrative civil money penalties. This rule implements the civil money penalty provisions of several statutes: the National Childhood Vaccine Injury Act of 1986 (NCVIA), the Prescription Drug Marketing Act of 1988 (PDMA), the Safe Medical Devices Act of 1990 (SMDA), the Generic Drug Enforcement Act of 1992 (GDEA), and the Mammography Quality Standards Act of 1992 (MQSA).