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Managing Editor, US Regulatory Analysis
Washington DC, USA
+26 year(s) experience
Pink Sheet
By Bridget Silverman 18 Feb 2020
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
By Bridget Silverman 14 Aug 2018
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
By Bridget Silverman 05 Aug 2017
First four 351(k) BLA approvals highlight emerging FDA positions on issues from naming to the role of biosimilar-specific data.
Topic Biosimilars
Pink Sheet
17 Feb 2020
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17 Feb 2020
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11 Feb 2020
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01 Dec 2019
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17 Nov 2019
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10 Nov 2019
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07 Nov 2019
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04 Nov 2019
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31 Oct 2019
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24 Oct 2019
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15 Oct 2019
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13 Oct 2019
Pink Sheet
13 Oct 2019
Pink Sheet
10 Oct 2019
Pink Sheet
06 Oct 2019
