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Managing Editor, US Regulatory Analysis
Washington DC, USA
+26 year(s) experience
Pink Sheet
The coronavirus pandemic could be a turning point for master protocol and platform trial designs, but clear guidance and coordination are still needed.
Topic Coronavirus
Pink Sheet
US FDA’s Medical Countermeasures Initiative authorities like emergency use authorization have not yet had much of an impact on drugs and biologics, but agency is committed to supporting a swift response to the new strain of coronavirus.
Pink Sheet
Differences in eligibility and evidentiary criteria between the US FDA's two expedited regulatory programs are reflected in a new guide; metrics to date suggest comparable success rates for designation requests under the two programs. Our infographics aid in understanding the programs.
Topic FDA
Pink Sheet
First four 351(k) BLA approvals highlight emerging FDA positions on issues from naming to the role of biosimilar-specific data.
Topic Biosimilars
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24 Oct 2020
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12 Oct 2020
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12 Oct 2020
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12 Oct 2020
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27 Sep 2020
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27 Sep 2020
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14 Aug 2020
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11 Aug 2020
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10 Aug 2020
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05 Aug 2020
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03 Aug 2020
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01 Aug 2020
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26 Jul 2020
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21 Jul 2020
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11 Jul 2020
