FDA finalizes guidance on REMS format and content

Regulatory NewsRegulatory News | 04 January 2023 |  By 

The US Food and Drug Administration (FDA) on Wednesday finalized guidance outlining its expectations for the format and content of a risk evaluation and mitigation strategy (REMS) document for certain high-risk prescription drugs and biologics that pose safety concerns and incorporates “extensive” stakeholder feedback, said the agency.
The draft version of the guidance was first issued for comment in 2017. (RELATED: REMS Format and Content: FDA Offers Draft Guidance, Regulatory Focus 11 October 2017)
The agency said the guidance and a related technical specifications document “are intended to help ensure that REMS documents are clear; understandable to stakeholders; and to the extent possible, consistent in content and format, as well as support submission of REMS document in Structured Product Labeling format, which is required starting December 28, 2022,” said FDA’s announcement.
The guidance describes the types of information that should be included in a REMS document, including its format and content, discusses FDA’s REMS authority, and describes considerations for changing the document format.
The update adds reference to a new statutory authority given to FDA under the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) enacted in October 2018.
Under this authority, FDA proposes that applicants provide mail-back envelopes and education on safe disposal be provided with opioid analgesics dispensed in outpatient settings. (RELATED: FDA proposes plan to mail back unused opioids, Regulatory Focus 20 April 2022)
The guidance states that “requirements related to packaging and disposal can include requirements for the applicant to make drug available for dispensing in certain packaging (e.g., unit dose) or implement a requirement that a disposal system be dispensed for the purpose of rendering the drug non retrievable). The packaging and disposal requirements can be required if they night mitigate a serious adverse event occurring from abuse or overdose.”
According to FDA, the final guidance also revises and clarifies participation requirements for complying with the REMS; adds a new section to list the statutory elements of the REMS; adds a prompt to identify to address the risk addressed by REMS; and relocates the information contained in the appendix of the guidance to a separate REMS technical specifications guidance
Congress established the REMS program in 2007; under the program, FDA requires manufacturers to implement specific safety measures that go beyond drug labeling requirements for certain medications with serious safety concern to ensure the benefits of the drug outweigh the risks.


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Tags: FDA, opioids, REMS

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