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Managing Editor, US Regulatory Analysis
Washington DC, USA
28+ years of experience
Pink Sheet
By Bridget Silverman 19 Jan 2022
US FDA’s accelerated approvals hit a contemporary high in 2021, accounting for one-third of novel US approvals, but the big story was the agency’s crackdown on delinquent confirmatory trials for oncology AA indications.
Pink Sheet
By Bridget Silverman 27 Nov 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 05 Jun 2020
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
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
25 Jun 2022
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23 Jun 2022
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21 Jun 2022
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20 Jun 2022
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02 Jun 2022
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31 May 2022
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26 May 2022
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12 May 2022
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02 May 2022
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02 May 2022
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28 Apr 2022
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18 Apr 2022
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12 Apr 2022
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31 Mar 2022
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24 Mar 2022
