Risk Management Plans (RMPs)

Risk management strategies have evolved over time, increasing in rigor in their efforts to curb continuing safety concerns. In the early 1990s, Risk Management Plans (RMPs) focused on the evaluation of risk and proper representation of that risk in approved labeling.
 
These early RMPs were designed to minimize the risk of misuse for opioids and nicotine. Second-generation programs focused on specific risks and their prevention; third-generation programs proposed to address all identifiable product risks.
 
In essence, RMPs are strategies that include risk assessments and these are reflected in the label.