FDA Finalizes REMS Guidance
The FDA guidance defines changes to approved risk evaluation and mitigation strategies and clarifies submission guidelines.
FDA published the final version of its REMS guidance document, Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry, on July 9, 2019. The guidance provides information on types of approved risk evaluation and mitigation strategies (REMS) and how applicants should submit changes to an approved REMS. The guidance also clarifies the differences between modifications of a REMS and revisions of a REMS.
FDA timeframes for assessing REMS changes-including revisions, minor modifications, major modifications, modifications due to safety labeling changes, and multiple types of REMS changes-are also included in the document. An appendix provides detailed submission procedures.
The guidance applies to all types of REMS but does not address additional submission procedures that may apply to application holders proposing changes to a shared system and that use a drug master file for their REMS submission.
Source: FDA
Market Demands and Emerging Technologies Shape Outsourcing Models
June 5th 2025Trends in certain forms of drug delivery, as well as the emergence of artificial intelligence, are playing roles in evolving the nature of partnerships, but there are new types of partnerships gaining steam as well.
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
