Depending on who you ask, black box warnings can fail to curb inappropriate prescribing or scare off patients who would benefit from an effective therapy. FDA is proposing a provider survey to find out what perceptions really are.
During a January US Food and Drug Administration advisory committee to consider potential actions to address a cardiovascular safety signal for Takeda Pharmaceutical Co. Ltd.’s gout therapy Uloric (febuxostat), committee member David Felson (Boston University) asked the FDA for some help.
The agency was seeking a vote from the committee on which of a series of potential actions to take, ranging...
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.
There are now three draft versions of the legislative text that will overhaul the framework governing pharmaceuticals in the EU. Lawyers explain how the approaches proposed by the European Commission, European Parliament and Council of the EU differ and highlight implications for industry.
