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2373 documents

Order February 7 2022

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer Court Documents · 2 pages

UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS FORT WORTH DIVISION PUBLIC HEALTH AND MEDICAL PROF ESSIONALS FOR TRANSPARENCY , Plaintiff, v. FOOD AND DRUG ADMINISTRATION , Defendant. No. 4:21-cv-1058 -P v. PFIZER , INC., Movant. ORDER Before the Court is Movant Pfizer, Inc .’s Motion to Intervene for a Limited Purpose (“Motion”) . ECF No. 40. On J anuary 2 8, 2022, the Court held a hearing on the M otion , where Pfizer …

056 ORDER GRANTING IN PART THE MOTION TO MODIFY THE PRODUCTION SCHEDULE AND ADDOPTS THE JOINT STATUS REPORT MODIFIED AGREED PRODUCTION SCHEDULE

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer Court Documents · 2 pages

UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS FORT WORTH DIVISION PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY , Plaintiff, v. No. 4:2 1-cv-1058-P FOOD AND DRUG ADMINISTRATION , Defendant. ORDER Before the Court is Defendant Food and Drug Administration ’s Motion to Partially Modify S cheduling Order ( “Motion ”). ECF No. 36. Also before the Court is a Joint Status Report that articulates the Parties ’ agreed production schedule…

047 PLAINTIFFS RESPONSE TO PFIZER INC.S MOTION FOR LEAVE TO INTERVENE FOR A LIMITED PURPOSE

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer Court Documents · 15 pages

i UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF TEXAS PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY, Plaintiff, -against - FOOD AND DRUG ADMINISTRATION, Defendant. Civil Action No. 4:21- cv-01058- P PLAINTIFF’S RESPONSE TO PFIZER INC.’S MOTION FOR LEAVE TO INTERVENE FOR A LIMITED PURPOSE Case 4:21-cv-01058-P Document 47 Filed 01/25/22 Page 1 of 15 PageID 2061Case 4:21-cv-01058-P Document 47 Filed…

046 RESPONSE filed by Food and Drug Administration re 40 MOTION to Intervene for a Limited Purpose

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer Court Documents · 4 pages

1 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS ____________________________________ ) PUBLIC HEALTH AND MEDICAL ) PROFESSIONALS FOR ) TRANSPARENCY, ) ) Plaintiff, ) ) v. ) Civil Action No. 4:21-cv-01058-P ) UNITED STATES FOOD AND DRUG ) ADMINISTRATION, ) ) Defendant. ) ___________________________________ ) DEFENDANT FOOD AND DRUG ADMINISTRATION’S RESPONSE TO PFIZER INC’S MOTION FOR LEA VE TO INTERVENE FOR A LIMITED…

044 PL PHPMTS MOL IN OPPOSITION TO DEFENDANTS MOTION TO MODIFY THE SCHEDULING ORDER OF THE COURT

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer Court Documents · 20 pages

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF TEXAS PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY, Plaintiff, -against - FOOD AND DRUG ADMINISTRATION, Defendant. Civil Action No. 4:21- cv-01058- P PLAINTIFF ’S MEMORANDUM OF LAW IN OPPOSITION TO DEFENDANT’S MOTION TO MODIFY THE SCHEDULING ORDER OF THE COURT Case 4:21-cv-01058-P Document 44 Filed 01/24/22 Page 1 of 20 PageID 1787Case 4:21-cv-01058-P Document 44 Filed…

041 Memorandum in Support filed by Pfizer Inc. re 40 MOTION to Intervene for a Limited Purpose

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer Court Documents · 16 pages

MEMORANDUM IN SUPPORT OF PFIZER INC.’S MOTION FOR LEAVE TO INTERVENE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS FORT WORTH DIVISION PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY Plaintiff, v. FOOD AND DRUG ADMINISTRATION Defendant. § § § § § § § § § § § § § § § § § § CASE NO. 4:21-CV-01058-P MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF PFIZER INC.’S MOTION FOR LEAVE TO INTERVENE FOR A…

038 Appendix in Support filed by FDA re 36 MOTION To Partially Modify Scheduling Order

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer Court Documents · 19 pages

EXHIBIT A APPX001Case 4:21-cv-01058-P Document 38 Filed 01/18/22 Page 1 of 19 PageID 1735Case 4:21-cv-01058-P Document 38 Filed 01/18/22 Page 1 of 19 PageID 1735 1IN THE UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF TEXAS PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY, Plaintiff, -against- FOOD AND DRUG ADMINISTRATION, Defendant.Civil Action No. 4:21-cv-01058-P SECOND DECLARATION OF SUZANN BURK I,Suzann Burk, hereby declare as follows: 1. I am the Director of…

037 Brief Memorandum in Support filed by FDA re 36 MOTION To Partially Modify Scheduling Order 1

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer Court Documents · 12 pages

1 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS ____________________________________ ) PUBLIC HEALTH AND MEDICAL ) PROFESSIONALS FOR ) TRANSPARENCY, ) ) Plaintiff, ) ) v. ) Civil Action No. 4:21- cv-01058- P ) UNITED STATES FOOD AND DRUG ) ADMINISTRATION, ) ) Defendant. ) ___________________________________ ) MEMORANDUM IN SUPPORT OF DEFENDANT ’S MOTION TO PARTIALLY MODIFY SCHEDULING ORDER INTRODUCTION …

ORDER 2022 01 06

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer Court Documents · 4 pages

UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS FORT WORTH DIVISION PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY , Plaintiff, v. No. 4:2 1-cv-1058-P FOOD AND DRUG ADMINISTRATION , Defendant. ORDER This case involves the Freedom of Information Act (“FOIA”). Specifically, at issue is Plaintiff’s FOIA request seeking “[a]ll data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e) with the exception of publicly…

032 Appendix in Support filed by Public Health and Medical Professionals for Transparency re 31 Reply

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer Court Documents · 150 pages

Page 1 of 2 UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF TEXAS PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY, P laintiff, -against - F OOD AND DRUG ADMINISTRATION, D efendant. C ivil Action No. 4:21- cv-01058-P APPENDIX IN SUPPORT OF PLAINTIFF’S OPPOSITION TO FDA’S REQUEST FOR AT LEAST 75 YEARS TO RELEASE PFIZER’S BLA DOCUMENTS Plaintiff Public Health and Medical Professional s for Transparency submits this Appendix in support of its Opposition to FDA’s…

031 REPLY filed by Public Health and Medical Professionals for Transparency re 22 Brief Memorandum in Support of Motion

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer Court Documents · 26 pages

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF TEXAS PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY, Plaintiff, -against - FOOD AND DRUG ADMINISTRATION, Defendant. Civil Action No. 4:21- cv-01058- P OPPOSITION TO FDA’S REQUEST FOR AT LEAST 75 YEARS TO RELEASE PFIZER’S BLA DOCUMENTS Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 1 of 26 PageID 1427Case 4:21-cv-01058-P Document 31 Filed 12/13/21 …

030 FDAs Appendix in Support of Brief

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer Court Documents · 36 pages

EXHIBIT D App111Case 4:21-cv-01058-P Document 30 Filed 12/13/21 Page 1 of 36 PageID 1391Case 4:21-cv-01058-P Document 30 Filed 12/13/21 Page 1 of 36 PageID 1391 IN T HE UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF TEXAS PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY, Plaintiff, -against- FOOD AND DRUG ADMINISTRATION, Defendant.Civil Action No. 4:21-cv-01058-P DE CLARATION OF SARAH B. KOTLER I, Sarah B. Kotler, declare as follows: 1. I am the Director of…

029 FDAs Reply re Brief in Support of Motion

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer Court Documents · 28 pages

1 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS ____________________________________ ) PUBLIC HEALTH AND MEDICAL ) PROFESSIONALS FOR ) TRANSPARENCY, ) ) Plaintiff, ) ) v. ) Civil Action No. 4:21-cv-01058-P ) UNITED STATES FOOD AND DRUG ) ADMINISTRATION, ) ) Defendant. ) ___________________________________ ) DEFENDANT’S REPLY BRIEF IN ADV ANCE OF SCHEDULING CONFERENCE INTRODUCTION This is a Freedom of Information Act…

027 Appendix in Support filed by Public Health and Medical Professionals for Transparency re 26 Brief Memorandum in Support of Motion

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer Court Documents · 633 pages

Page 1of 2 UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF TEXAS PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY, Plaintiff, -against- FOOD AND DRUG ADMINISTRATION, Defendant.Civil Action No. 4:21-cv-01058-P APPENDIX IN SUPPORT OF BRIEF FOR TIMELY PRODUCTION NOW COMES, Plaintiff Public Health and Medical Professionals for Transparency and files this Appendix in Support of its Brief for Ti mely Productio n. Exhibit Description Page No. A Declaration of Peter McCullough, MD,…

026 Brief Memorandum in Support filed by Public Health and Medical Professionals for Transparency re 21 Order Setting DeadlineHearing

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer Court Documents · 30 pages

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF TEXAS PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY, Plaintiff, -against - FOOD AND DRUG ADMINISTRATION, Defendant. Civil Action No. 4:21- cv-01058- P BRIEF IN SUPPORT OF TIMELY PRODUCTION Case 4:21-cv-01058-P Document 26 Filed 12/07/21 Page 1 of 30 PageID 697Case 4:21-cv-01058-P Document 26 Filed 12/07/21 Page 1 of 30 PageID 697 Page ii TABLE OF…

023 FDA Appendix in Support 1

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer Court Documents · 110 pages

Exhibit A App001Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 1 of 110 PageID 240Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 1 of 110 PageID 240 App002Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 2 of 110 PageID 241Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 2 of 110 PageID 241 App003Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 3 of 110 PageID 242Case 4:21-cv-01058-P Document 23 Filed 12/06/21 Page 3…

022 FDA Brief in Advance of Scheduling Conference

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer Court Documents · 19 pages

IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS ____________________________________ ) PUBLIC HEALTH AND MEDICAL ) PROFESSIONALS FOR ) TRANSPARENCY, ) ) Plaintiff, ) ) v. ) Civil Action No. 4:21- cv-01058- P ) UNITED STATES FOOD AND DRUG ) ADMINISTRATION, ) ) Defendant. ) ___________________________________ ) DEFENDANT’S BRIEF IN ADVANCE OF SCHEDULING CONFERENCE Case 4:21-cv-01058-P Document 22 Filed 12/06/21 …

111521 Second Joint Status Report

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer Court Documents · 14 pages

Page 1 of 14 IN THE UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF TEXAS PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY , Plaintiff, -against - FOOD AND DRUG ADMINISTRATION , Defendant. Civil Action No. 4:21-cv-01058 -P SECOND JOINT REPORT Plaintiff, Public Health and Medical Professionals for Transparency (“ Plaintiff ”), by and through its attorneys, and Defendant, the U.S. Food and Drug Administration (“ Defendant or “FDA ”),…

091621 Complaint

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer Court Documents · 37 pages

Page 1 of 2 UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF TEXAS PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY, Plaintiff, -against - FOOD AND DRUG ADMINISTRATION, Defendant. Civil Action No. ____________ COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF Plaintiff, as for its Complaint regarding a Freedom of Information Act request against the above -captioned Defendant, alleges as follows: INTRODUCTION 1. Until only a few weeks…

125742 45 S211 M5 havers fp 2021

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 7 pages

Morbidity and Mortality Weekly Report MMWR / June 11, 2021 / Vol. 70 / No. 23 851 US Department of Health and Human Services/Centers for Disease Control and PreventionHospitalization of Adolescents Aged 12–17 Years with Laboratory-Confirmed COVID-19 — COVID-NET, 14 States, March 1, 2020–April 24, 2021 Fiona P . Havers, MD1; Michael Whitaker, MPH1; Julie L. Self, PhD1; Shua J. Chai, MD2,3; Pam Daily Kirley, MPH2; Nisha B. Alden, MPH4; Breanna Kawasaki, MPH4; James Meek, MPH5; Kimberly…