FDA says therapy for relapsing multiple sclerosis should be reserved for patients who fail two or more other MS treatments; REMS includes four-year follow up.
Genzyme Corp. finally gained approval for its multiple sclerosis treatment Lemtrada, but may face an uphill battle for patients due to its restrictive label and REMS.
FDA recommended the product be used as a third-line treatment because of its safety profile. Its risk mitigation program also...
The Trump Administration’s rhetoric and policy approaches illustrate the confusion that often arises between efforts to cut drug prices and cutting spending.
Companies with significant exposure to Medicare and Medicaid have fewer options for passing along higher costs to consumers because of price controls in the programs.
The news coincides with rumors that Commissioner Martin Makary soon will name a new Center for Drug Evaluation and Research director.
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.
Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
