A nasal spray that contains esketamine — a potent derivative of ketamine — can now be taken on its own to treat adults with ...

Unfortunately, an FDA policy — specifically the Risk Evaluation and Mitigation Strategies (REMS) program — has been largely responsible for the underprescription and underuse of clozapine ...

necessitates a REMS program, a “Patient Agreement Form,” and a “Black Box” warning. And it suggests FDA’s actions are well “outside the zone of reasonableness.” It’s unreasonable ...

In the first 22 months of a mavacamten REMS program, few patients needed a temporary interruption in treatment for LVEF below 50%.

An emerging treatment for clinical depression has reached an important milestone. This week, the Food and Drug Administration approved Johnson & Johnson’s ketamine-based nasal spray, Spravato, as a ...

Purpose The results of a hospital's initiative to evaluate and improve compliance with federally mandated risk evaluation and mitigation strategies (REMS) are presented. Summary Food and Drug ...

The growing disproportionate amount of drug spending on such a small subset ... the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program. Finally, some pharmaceutical manufacturers ...

However, Spravato remains restricted under the FDA's REMS program due to its abuse potential. Investors will watch how this regulatory win impacts Johnson & Johnson's pharma segment ahead of earnings.

On a practical level, the new guidance has the potential to delay a drug's approval process. For BioDelivery Sciences, in Raleigh, North Carolina, the agency's request for a REMS program had a ...