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        <title>Vanda Pharmaceuticals Inc. et al v. Food and Drug Administration et al :: Justia Dockets &amp; Filings</title>
        <link>https://dockets.justia.com/docket/texas/txsdce/4:2025cv01648/2000953</link>
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        <pubDate>Sun, 08 Nov 2026 18:00:20 -0800</pubDate>
        <lastBuildDate>Sun, 08 Nov 2026 18:00:20 -0800</lastBuildDate>
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        <copyright>Copyright 2026 Justia Inc</copyright>
        <description>Vanda Pharmaceuticals Inc. et al v. Food and Drug Administration et al - Docket Entries - Showing 1 through 26</description>
                                    <item>
        <title>
                            <![CDATA[Document 26]]>
                    </title>
                <description>
            <![CDATA[
                NOTICE of Dismissal as to Ally Totah, Mary Talley Bowden, Vanda Pharmaceuticals Inc., Food and Drug Administration, Robert F Kennedy Jr, Martin A. Makary, United States Department of Health and Human Services by Ally Totah, Mary Talley Bowden, Vanda Pharmaceuticals Inc., filed. (Hughes, Paul)
            ]]>
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                    <guid isPermaLink="false">https://dockets.justia.com#entry_30607801</guid>
                <pubDate>
            Wed, 01 Oct 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 25]]>
                    </title>
                <description>
            <![CDATA[
                ORDER granting #23 Motion for Connor J. Suozzo to Appear Pro Hac Vice Note: Instructions to request Texas Southern CM/ECF registration through PACER are found #here.(Signed by Judge Andrew S Hanen) Parties notified. (jld4)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_30607802</guid>
                <pubDate>
            Tue, 23 Sep 2025 00:00:00 -0700
        </pubDate>
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                        <item>
        <title>
                            <![CDATA[Document 24]]>
                    </title>
                <description>
            <![CDATA[
                RESPONSE in Opposition to #20 MOTION to Dismiss (or, in the Alternative, to Transfer), filed by Mary Talley Bowden, Ally Totah, Vanda Pharmaceuticals Inc.. (Attachments: #1 DECLARATION OF MARY TALLEY BOWDEN, M.D., #2 DECLARATION OF MIHAEL H. POLYMEROPOULOS, M.D., #3 Proposed Order) (Hughes, Paul)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_30607803</guid>
                <pubDate>
            Mon, 22 Sep 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 23]]>
                    </title>
                <description>
            <![CDATA[
                MOTION to Appear Pro Hac Vice for Connor J. Suozzo (Fee Paid: $100, receipt number ATXSDC-34174589) by Mary Talley Bowden, Ally Totah, Vanda Pharmaceuticals Inc., filed. Motion Docket Date 10/14/2025. (Hughes, Paul)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_30607804</guid>
                <pubDate>
            Mon, 22 Sep 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 22]]>
                    </title>
                <description>
            <![CDATA[
                ORDER granting #21 Motion to Modify.(Signed by Judge Andrew S Hanen) Parties notified. (rsh4)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_30607805</guid>
                <pubDate>
            Tue, 16 Sep 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 21]]>
                    </title>
                <description>
            <![CDATA[
                Joint MOTION to Modify Briefing Schedule by Food and Drug Administration, Robert F Kennedy Jr, Martin A. Makary, United States Department of Health and Human Services, filed. Motion Docket Date 9/29/2025. (Attachments: #1 Proposed Order) (Pezzi, Stephen)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_30607806</guid>
                <pubDate>
            Mon, 08 Sep 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 20]]>
                    </title>
                <description>
            <![CDATA[
                MOTION to Dismiss (or, in the Alternative, to Transfer) by Food and Drug Administration, Robert F Kennedy Jr, Martin A. Makary, United States Department of Health and Human Services, filed. Motion Docket Date 9/12/2025. (Attachments: #1 Ex. 1 - FDA's Complete Response Letter (Aug. 16, 2019), #2 Ex. 2 - FDA Correspondence (Aug. 25, 2022), #3 Ex. 3 - FDA's 2025 Guidance, #4 Proposed Order) (Pezzi, Stephen)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_30607807</guid>
                <pubDate>
            Fri, 22 Aug 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 19]]>
                    </title>
                <description>
            <![CDATA[
                MOTION for Extension of Time to Answer or Otherwise Respond to the Complaint (Current Deadline is Today, Aug. 15, 2025) by Food and Drug Administration, Robert F Kennedy Jr, Martin A. Makary, United States Department of Health and Human Services, filed. Motion Docket Date 9/5/2025. (Attachments: #1 Ex. 1 - Vanda v. FDA (D.C. Cir. Aug. 15, 2025), #2 Proposed Order) (Pezzi, Stephen)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_30607808</guid>
                <pubDate>
            Fri, 15 Aug 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 18]]>
                    </title>
                <description>
            <![CDATA[
                REPLY in Support of #13 MOTION to Stay Discovery and Case-Management Deadlines Pending Resolution of Defendants' Motion to Dismiss (or Transfer), filed by Food and Drug Administration, Robert F Kennedy Jr, Martin A. Makary, United States Department of Health and Human Services. (Pezzi, Stephen)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_30607809</guid>
                <pubDate>
            Wed, 13 Aug 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 17]]>
                    </title>
                <description>
            <![CDATA[
                RESPONSE in Opposition to #13 MOTION to Stay Discovery and Case-Management Deadlines Pending Resolution of Defendants' Motion to Dismiss (or Transfer), filed by Mary Talley Bowden, Ally Totah, Vanda Pharmaceuticals Inc.. (Attachments: #1 Proposed Order) (Hughes, Paul)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_30607810</guid>
                <pubDate>
            Tue, 05 Aug 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 16]]>
                    </title>
                <description>
            <![CDATA[
                NOTICE Notice of Change of Law Firm Name by Mary Talley Bowden, Ally Totah, Vanda Pharmaceuticals Inc., filed. (Hughes, Paul)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_30607811</guid>
                <pubDate>
            Mon, 04 Aug 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 15]]>
                    </title>
                <description>
            <![CDATA[
                NOTICE of Resetting AS TO LOCATION ONLY. Parties notified. Initial Conference set for 10/10/2025 at 09:30 AM by video before Magistrate Judge Yvonne Y Ho, filed. A Zoom link will be emailed to the parties the day before the hearing. (rlw4)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_30607812</guid>
                <pubDate>
            Tue, 22 Jul 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 14]]>
                    </title>
                <description>
            <![CDATA[
                NOTICE of Resetting to allow #13 to be fully briefed. Parties notified. Initial Conference set for 10/10/2025 at 09:30 AM in Courtroom 704 before Magistrate Judge Yvonne Y Ho, filed. (rlw4)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_30607813</guid>
                <pubDate>
            Tue, 22 Jul 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 13]]>
                    </title>
                <description>
            <![CDATA[
                MOTION to Stay Discovery and Case-Management Deadlines Pending Resolution of Defendants' Motion to Dismiss (or Transfer) by Food and Drug Administration, Robert F Kennedy Jr, Martin A. Makary, United States Department of Health and Human Services, filed. Motion Docket Date 8/6/2025. (Attachments: #1 Proposed Order) (Pezzi, Stephen)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_30607814</guid>
                <pubDate>
            Wed, 16 Jul 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 12]]>
                    </title>
                <description>
            <![CDATA[
                ORDER granting #11 Motion for Extension of Time Answer due by 8/15/2025.(Signed by Judge Andrew S Hanen) Parties notified. (rsh4)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_30607815</guid>
                <pubDate>
            Mon, 09 Jun 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 11]]>
                    </title>
                <description>
            <![CDATA[
                Unopposed MOTION for Extension of Time to Answer or Otherwise Respond to the Complaint by Food and Drug Administration, Robert F Kennedy Jr, Martin A. Makary, United States Department of Health and Human Services, filed. Motion Docket Date 6/27/2025. (Attachments: #1 Proposed Order) (Pezzi, Stephen)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_29024103</guid>
                <pubDate>
            Fri, 06 Jun 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 10]]>
                    </title>
                <description>
            <![CDATA[
                NOTICE of Appearance by Stephen M. Pezzi on behalf of Food and Drug Administration, Robert F Kennedy Jr, Martin A. Makary, United States Department of Health and Human Services, filed. (Pezzi, Stephen)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_29024104</guid>
                <pubDate>
            Thu, 29 May 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 9]]>
                    </title>
                <description>
            <![CDATA[
                CERTIFICATE OF INTERESTED PARTIES by Mary Talley Bowden, Ally Totah, Vanda Pharmaceuticals Inc., filed. (Hughes, Paul)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_29024105</guid>
                <pubDate>
            Fri, 25 Apr 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 7]]>
                    </title>
                <description>
            <![CDATA[
                CERTIFICATE OF SERVICE of #4 Order for Initial Conference - FORM, #5 MOTION to Appear Pro Hac Vice for Paul. W. Hughes (Fee Paid: $100, receipt number ATXSDC-33239206), #1 Complaint,, #3 Clerks Notice re Consent to Jurisdiction of Magistrate Judge, #6 Summons Issued as to USA by Mary Talley Bowden, Ally Totah, Vanda Pharmaceuticals Inc., filed. (Salgado, Richard)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_29024106</guid>
                <pubDate>
            Thu, 17 Apr 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 8]]>
                    </title>
                <description>
            <![CDATA[
                ORDER granting #5 Motion for Paul W Hughes to Appear Pro Hac Vice Note: Instructions to request Texas Southern CM/ECF registration through PACER are found #here.(Signed by Judge Andrew S Hanen) Parties notified. (jld4)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_29024107</guid>
                <pubDate>
            Wed, 16 Apr 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 6]]>
                    </title>
                <description>
            <![CDATA[
                Summons Issued as to All Defendants, U.S. Attorney and U.S. Attorney General. Issued summons returned to plaintiff by NEF, filed. (rlm4)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_29024108</guid>
                <pubDate>
            Tue, 15 Apr 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 5]]>
                    </title>
                <description>
            <![CDATA[
                MOTION to Appear Pro Hac Vice for Paul. W. Hughes (Fee Paid: $100, receipt number ATXSDC-33239206) by Mary Talley Bowden, Ally Totah, Vanda Pharmaceuticals Inc., filed. Motion Docket Date 5/5/2025. (Hughes, Paul)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_29024109</guid>
                <pubDate>
            Mon, 14 Apr 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 4]]>
                    </title>
                <description>
            <![CDATA[
                ORDER for Initial Pretrial and Scheduling Conference and Order to Disclose Interested Persons. Initial Conference set for 8/1/2025 at 09:30 AM by video before Magistrate Judge Yvonne Y Ho. (Signed by Magistrate Judge Yvonne Y Ho) Parties notified. (bkt4)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_28350664</guid>
                <pubDate>
            Thu, 10 Apr 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 3]]>
                    </title>
                <description>
            <![CDATA[
                CLERKS NOTICE Regarding Consent to Jurisdiction of Magistrate Judge. Parties notified, filed. (bkt4)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_28350665</guid>
                <pubDate>
            Thu, 10 Apr 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Docket Entry]]>
                    </title>
                <description>
            <![CDATA[
                Referral Judge Selected: Magistrate Judge Yvonne Y. Ho randomly selected to receive referrals. The selected Magistrate Judge is not assigned to this case until a District Judge refers the case or a motion or the parties consent to jurisdiction of the Magistrate Judge. Once a referral has been made, the name of the referral judge will appear at the top of the docket sheet. (bkt4)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_28350666</guid>
                <pubDate>
            Thu, 10 Apr 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 2]]>
                    </title>
                <description>
            <![CDATA[
                Request for Issuance of Summons as to Food and Drug Administration, Robert F Kennedy Jr, Martin A. Makary, United States Department of Health and Human Services, United States Attorney General, United States Attorney for the Southern District of Texas, filed. (Attachments: #1 Summons, #2 Summons, #3 Summons, #4 Summons, #5 Summons) (Salgado, Richard)
            ]]>
        </description>
                    <guid isPermaLink="false">https://dockets.justia.com#entry_28350667</guid>
                <pubDate>
            Wed, 09 Apr 2025 00:00:00 -0700
        </pubDate>
    </item>
                        <item>
        <title>
                            <![CDATA[Document 1]]>
                    </title>
                <description>
            <![CDATA[
                COMPLAINT against Food and Drug Administration, Robert F Kennedy Jr, Martin A. Makary, United States Department of Health and Human Services (Filing fee $ 405 receipt number ATXSDC-33222270) filed by Vanda Pharmaceuticals Inc., Ally Totah, Mary Talley Bowden. (Attachments: #1 Exhibit A, #2 Exhibit B, #3 Exhibit C, #4 Exhibit D, #5 Exhibit E, #6 Exhibit F, #7 Exhibit G, #8 Exhibit H, #9 Exhibit I, #10 Exhibit J, #11 Exhibit K, #12 Exhibit L, #13 Civil Cover Sheet) (Salgado, Richard)
            ]]>
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                <pubDate>
            Wed, 09 Apr 2025 00:00:00 -0700
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