Regulatory Terms Starting With R

Real-World Evidence (RWE)

Clinical evidence about the use, potential benefits, or risks of a medical product derived from analysis of real-world data.

Reference Listed Drug (RLD)

An FDA-approved drug product identified in the Orange Book that a generic drug sponsor relies on for an Abbreviated New Drug Application.

Refuse to Accept (RTA)

FDA's decision not to accept a 510(k) submission for substantive review due to administrative or completeness deficiencies.

Refuse to File (RTF)

FDA's decision not to accept a drug or biologic marketing application for substantive review due to administrative or content deficiencies.

Risk Evaluation and Mitigation Strategy (REMS)

A drug safety program required by FDA for certain medications with serious safety concerns to ensure benefits outweigh risks.

Risk Management Plan (RMP)

A document describing safety activities to identify, characterize, prevent, and minimize risks relating to medicinal products.