Ibrance Illustrates Heavy FDA Workload For 'Breakthrough' Reviews
Approval of Pfizer's breast cancer therapy palbociclib on the basis of Phase II data required an exhaustive set of statistical sensitivity analyses and a striking number of pre-NDA meetings.
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US FDA approved expanded label for male breast cancer based on a supplement that included only non-traditional data sets. But agency is making clear that the “substantial” evidence for efficacy still came from the traditional pivotal trials – in women.
21st Century Cures legislation also criticized in JAMA Internal Medicine editorial.
FDA review documents for Sandoz’s filgrastim-sndz suggest that biosimilar sponsors need to consider how differences in delivery device from the reference product will play out under the 351(k) pathway, including whether new device designs and human factors data will be needed to secure interchangeability.