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Recent items include:

  • <![CDATA[The Industry’s Communication and Engagement with FDA]]>
  • <![CDATA[FDA Pauses Release of New CRL’s Following Citizen’s Petition ]]>
  • <![CDATA[FDA Expands Enhertu in Early HER2-Positive Breast Cancer]]>

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pharmexec.com /1 month ago

&lt;![CDATA[The Industry’s Communication and Engagement with FDA]]&gt;

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pharmexec.com /5 days ago

&lt;![CDATA[FDA Pauses Release of New CRL’s Following Citizen’s Petition ]]&gt;

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pharmexec.com /1 month ago

&lt;![CDATA[FDA Expands Enhertu in Early HER2-Positive Breast Cancer]]&gt;

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pharmexec.com /1 month ago

&lt;![CDATA[The Evolving Relationship Between FDA and Biotech]]&gt;

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pharmexec.com /6 days ago

&lt;![CDATA[Pharmaceutical Executive Daily: FDA Approves Ennumo]]&gt;

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pharmexec.com /1 month ago

&lt;![CDATA[FDA’s New Pilot Program and Real-Time Review of Clinical Data]]&gt;

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pharmexec.com /1 month ago

&lt;![CDATA[FDA Makes Leadership Overhaul Following Commissioner Makary’s Departure: Report ]]&gt;

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pharmexec.com /1 month ago

&lt;![CDATA[FDA Sends CRL to Cingulate for CTx-1301]]&gt;

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pharmexec.com /3 weeks ago

&lt;![CDATA[FDA Advisory Committee Votes Unanimously in Favor of the Benefit-Risk Profile of mRNA-1010 ]]&gt;

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pharmexec.com /1 month ago

&lt;![CDATA[Pharmaceutical Executive Daily: FDA Approves Datroway]]&gt;

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pharmexec.com /6 days ago

&lt;![CDATA[U.S. Supreme Court Weighs Inducement Liability Beyond FDA Carve-Out Labels]]&gt;

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pharmexec.com /2 days ago

&lt;![CDATA[FDA Issues CRL to Elevar Therpaeutics for Combination of Rivoceranib and Camrelizumab ]]&gt;

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pharmexec.com /1 month ago

&lt;![CDATA[FDA's Timeline for DTC Prescription Drug Ad Oversight]]&gt;

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pharmexec.com /3 weeks ago

&lt;![CDATA[FDA Pilot Targets Faster Early-Stage Drug Trial Starts]]&gt;

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pharmexec.com /1 month ago

&lt;![CDATA[The Risks and Benefits of FDA Reviewing Real-Time Data]]&gt;

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pharmexec.com /2 weeks ago

&lt;![CDATA[FDA Announces Seven Participants to PreCheck Pilot Program]]&gt;

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pharmexec.com /1 month ago

&lt;![CDATA[New FDA Draft Guidance Targets Gene Therapy Submission Burden by Allowing Use of Existing CMC and Scientific...

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pharmexec.com /1 month ago

&lt;![CDATA[FDA Accepts NDA for Giredestrant in ER-Positive Early-Stage Breast Cancer]]&gt;

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pharmexec.com /3 weeks ago

&lt;![CDATA[Pharmaceutical Executive Daily: FDA Approves Utebzi and Capvaxive]]&gt;

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pharmexec.com /1 month ago

&lt;![CDATA[Pharmaceutical Executive Daily: FDA Approves Xocova]]&gt;

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pharmexec.com /1 month ago

&lt;![CDATA[The Push at FDA to Tighten Oversight on DTC Prescription Drug Ads]]&gt;

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pharmexec.com /1 month ago

&lt;![CDATA[What Does the Regulatory Landscape Look Like From the Other Side of FDA?]]&gt;

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pharmexec.com /5 days ago

&lt;![CDATA[FDA Approves Subcutaneous Sarclisa Escena for Multiple Myeloma ]]&gt;

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natlawreview.com /4 weeks ago

FDA Issues Draft Guidance Clarifying Use of Form FDA 3542

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Sources covering <![Cdata[Fda]]>

natlawreview.com

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pharmexec.com

Recent coverage from public sources
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