Regulatory Terms Starting With R

6 terms in the R index.

• Real-World Evidence (RWE)

  Real-World Evidence is clinical evidence about a medical product's usage, benefits, or risks derived from data generated outside traditional clinical trials, such as health records, claims, and registries, rather than from a protocol-driven randomized study.

• Refuse to Accept (RTA)

  Refuse to Accept is FDA's administrative decision that a device premarket submission is too incomplete to enter substantive review, a completeness gate applied before any scientific assessment of the device begins.

• Refuse to File (RTF)

  Refuse to File is FDA's determination, made within 60 days of receiving an NDA, that the application is not sufficiently complete to permit a substantive review, so no filing date and no review clock begin.

• Risk Evaluation and Mitigation Strategy (REMS)

  Risk Evaluation and Mitigation Strategy (REMS) is an FDA-mandated drug safety program that imposes enforceable conditions on prescribing, dispensing, or patient monitoring whenever FDA determines those conditions are necessary to ensure a drug's benefits outweigh its risks.

• RLD (Reference Listed Drug)

  An RLD is the FDA-approved listed drug an ANDA relies on as its legal basis, setting the active ingredient, dosage form, strength, route, conditions of use, and labeling the generic must match.

• RMP (Risk Management Plan)

  RMP is the EU regulatory document that records a medicinal product's risk management system: the important identified risks, important potential risks, and missing information, plus the pharmacovigilance and risk-minimisation activities that address them.