While FDA may envision suffix selection to be simple, sponsors and branding firms see a much more involved process.
Whether it was a mistake as FDA indicated or a trial balloon that quickly burst, the agency generated substantial buzz over its short-lived idea to require that biosimilar sponsors propose 10 potential nonproprietary name suffixes.
Concerns may have arisen in part because of the work and cost that could be involved in selecting the random...
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.
