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.
Pharmaceutical Tariffs Are Imminent: How Industry is Bracing for Impact
April 16th 2025On April 14, 2025, the Trump Administration launched a national security-driven investigation into pharmaceuticals, a move that will likely result in tariffs being placed on pharmaceutical drugs, ingredients, and other components that are imported from outside of the United States.
