REMS: Added Expense For Pharma, Added Opportunity For Suppliers
The first anniversary of REMS is March 25: one year from the effective date of the FDA Amendments Act provisions granting FDA authority to require Risk Evaluation and Mitigation Strategies for drugs that raise safety issues
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FDA is starting the process of developing a classwide Risk Evaluation & Mitigation Strategy for potent opioid drug products - with the resulting program expected to be the most extensive REMS required by the agency since the implementation of the FDA Amendments Act
Celgene's arguments against generics of Thalomid (thalidomide) offer another example of the potentially vast consequences of FDA's new safety powers: The firm is arguing that the complexity of its risk management plan precludes the approval of alternate versions of the product
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