Description
This guidance provides updated recommendations for the format and content of a risk evaluation and mitigation strategy (REMS) document for a prescription drug product, including a biological drug product. A REMS document, which is part of a REMS that is required by FDA, establishes the goals and requirements of the REMS.
Scope & Applicability
Stakeholders
5Entity submitting development data and knowledge; Entity performing the work process for change
Prescribers 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
Participants involved in the distribution process of REMS drugs
FDA does not expect application holders of approved REMS to submit a proposed REMS modification solely to convert format.
Identified Hazards
Hazards
2Serious risks for which packaging and disposal technologies may be required
Risks occurring from abuse or overdose that REMS aims to mitigate
Related CFR Sections (4)
- 21CFR201.15§ 201.15 Drugs; prominence of required label statements.
(a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 502(c) of the act by reason, among other reasons, of:Read full regulation →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
- 21CFR314.97§ 314.97 Supplements and other changes to an approved ANDA.
(a) General requirements. The applicant must comply with the requirements of §§ 314.70 and 314.71 regarding the submission of supplemental ANDAs and other changes to an approved ANDA.Read full regulation →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
See Also (8)
- Postapproval Changes to Drug Substances Guidance for Industry (Status: Draft)
- SUPAC-IR Questions and Answers about SUPAC-IR Guidance (Status: Final)
- Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry (Status: Draft)
- Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry (Status: Final)
- Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (Status: Final)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
- Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability (Status: Final)
- For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h: Guidance for Industry (Status: Final)