Biosimilars will have same pharmacovigilance expectations as innovator biologics despite lack of clinical data for some extrapolated indications.
FDA dealt another blow to opponents of biosimilar indication extrapolation when it stated that there would be no unique post-marketing requirements for products approved under the 351(k) pathway.
Arthritis Advisory Committee members began asking about the post-marketing requirements early during a Feb. 9 meeting on Celltrion Inc.'s...
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.
