FDA Updates Approved REMS
FDA gives an update on currently approved Risk Evaluation and Mitigation Strategies.
FDA has updated its approved Risk Evaluation and Mitigation Strategies (REMS). FDA requires REMS from manufacturers to ensure that the potential risks posed by drug products are outweighed by the benefits to patient health.
Products affected by the updates to the approved REMS include:
- Xeljianz (tofacitinib) tablets
- Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)
- Extended-Release and Long-Acting Opioid Analgesics REMS
- Mycophenolate REMS
- Rosiglitazone REMS
- Transmucosal Immediate-Release Fentanyl (TIRF) Products
More information can be found at FDA.gov.
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.
