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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Meeting management and some application assessment changes also may be necessary as stakeholders prepare for the second biosimilar user fee program reauthorization.
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.
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.