Playing It Safe? Hahn's Biosimilar View
US FDA Commissioner nominee gave a general, scripted answer to a question about biologic patents, but did Stephen Hahn inadvertently go against the agency's stance on the issue?
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BsUFA III: Could Regulatory Science Research Emerge With Other Tweaks?
Meeting management and some application assessment changes also may be necessary as stakeholders prepare for the second biosimilar user fee program reauthorization.
Stability Key For US FDA, But Changes Needed For Consumer Health Are Clear
Some stakeholders in regulated industries are concerned that without a history as a public agency executive, Stephen Hahn could have an unpredictable tenure as FDA commissioner. Still, consumer health industry trade groups note regulatory topics crucial to the industry's growth and consumer safety should be clear.
Stephen Hahn Should Focus On Stability In First Days As US FDA Commissioner, Stakeholders Say
Among Hahn's primary duties should be to reassure staff that he will not be making radical changes and begin working on a priority list, experts told the Pink Sheet.