Although clinicians and advocates applauded the US Food and Drug Administration (FDA)’s recent decision to discontinue a risk management and evaluation program for the antipsychotic clozapine, some ...
This is just the fourth time in FDA’s history that it has waived an SSS REMS for generic competitors. Because the process of creating an SSS can be time-consuming and complex, such a determination to ...
It was only about a year ago that the biopharma industry hailed a decision by the Supreme Court to preserve access to mifepristone, a drug most commonly known for its paired use with another medicine ...
Two US Food and Drug Administration (FDA) advisory panels are urging the agency to eliminate the risk management program for the antipsychotic drug clozapine, saying that restrictions are limiting ...
A joint FDA advisory committee on Tuesday overwhelming voted to eliminate the risk evaluation and mitigation strategy (REMS) program designed around the risk for severe neutropenia associated with ...
A report from the Government Accountability Office (GAO) released Thursday finds that generic and branded drugmakers are split over the US Food and Drug Administration (FDA) and Federal Trade ...
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