Among 196 doctors who prescribed clozapine, 64% said the positive aspects of the REMS certification process outweighed the ...

If the FDA follows an advisory committee’s vote, it can potentially be a transformative step in the delivery of mental health ...

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

"While ensuring drug safety is essential," Singer and Bloom write, "the REMS program has unintentionally created barriers that disproportionately affect individuals with severe mental illnesses ...

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 ...

It is available only through a restricted REMS program. The FDA has approved a supplemental new drug application for Spravato, an esketamine nasal spray that can be used as monotherapy for adults ...

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 ...

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 ...

Morgan Stanley analyst Jeffrey Hung upgraded Cytokinetics (CYTK) to Overweight from Equal Weight with a price target of $67, down from $70. The ...