Description
This guidance is intended to clarify how the Food and Drug Administration (FDA or Agency) applies the factors set forth in section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1) in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh its risks.2This guidance fulfills one of the performance goals that FDA agreed to satisfy in the reauthorization of the Prescription Drug User Fee Act (PDUFA) V.3
Scope & Applicability
Product Classes
2A situation requiring additional pediatric safety data collection.
development program for drug and biological products
Stakeholders
4Prescribers who may require particular training or certification; health care providers' attitudes about the risk and safe-use interventions
Participants that dispense the drug and may require certification
Entity submitting development data and knowledge; Entity performing the work process for change
Healthcare provider who must be informed of specific conditions
Regulatory Context
Attributes
2Impact of treatment length on the likelihood and severity of adverse events
The overall assessment of a drug's safety and effectiveness
Identified Hazards
Hazards
2Specific risks associated with a drug that may necessitate ETASU
Occurrence associated with the drug that may require risk management
Related CFR Sections (4)
- 21CFR314.520§ 314.520 Approval with restrictions to assure safe use.
(a) If FDA concludes that a drug product shown to be effective can be safely used only if distribution or use is restricted, FDA will require such postmarketing restrictions as are needed to assure safe use of the drug product, such as:Read full regulation →
- 21CFR601.42§ 601.42 Approval with restrictions to assure safe use.
(a) If FDA concludes that a biological product shown to be effective can be safely used only if distribution or use is restricted, FDA will require such postmarketing restrictions as are needed to assure safe use of the biological product, such as:Read full regulation →
- 21CFR201.56§ 201.56 Requirements on content and format of labeling for human prescription drug and biological products.
(a) General requirements. Prescription drug labeling described in § 201.100(d) must meet the following general requirements:Read full regulation →
- 21CFR312.300§ 312.300 General.
(a) Scope. This subpart contains the requirements for the use of investigational new drugs and approved drugs where availability is limited by a risk evaluation and mitigation strategy (REMS) when the primary purpose is to diagnose, monitor, or treat a patient's disease or condition. The aim of thisRead full regulation →
See Also (8)
- Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Final)
- General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases: Guidance for Industry (Status: Final)
- Labeling for Biosimilar Products Guidance for Industry (Status: Final)
- Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format: Draft Guidance for Industry (Status: Draft)
- Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry: Guidance for Industry (Status: Final)
- Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry: Guidance for Industry (Status: Final)
- Regulatory Considerations for Prescription Drug Use-Related Software (Status: Draft)
- Clinical Pharmacology Considerations for Peptide Drug Products (Status: Draft)