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The following results were found for the term(s): pfizer
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URL: https://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4235S1-02-01-PfizerInc_files/slide1101.htm
This text was captured on Apr 07, 2017 Show All Captures
Pfizer Slides - Fragmin 8 Regulatory Background Dalteparin sNDA 20-287 S-035 i March 16, 2004 - Pfizer submitted sNDA for an indication in patients with VTE and cancer supported by data from the “CLOT”
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URL: https://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4090OPH1_08_Eisner_files/slide0005.htm
This text was captured on Apr 08, 2017 Show All Captures
pfizer capsule study 6 Hypothesis • The combination of a non-specific NSAID + PPI will be associated with a rate of small bowel mucosal breaks that is significantly higher than the rate for placebo or
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This text was captured on Apr 08, 2017 Show All Captures
Pfizer June 15 20 Conclusion i i This non-inferiority analysis provides an illustrative example of how one can use an active controlled trial to support an outcomes claim.
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URL: https://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4090OPH1_08_Eisner_files/slide0074.htm
This text was captured on Apr 08, 2017 Show All Captures
pfizer capsule study 4 Rates of Serious Lower GI Events per 100 Patients-Years in Patients Receiving Rofecoxib vs Naproxen 0.41 0.89 0 0.2 0.4 0.6 0.8 1.0 % of Patients with Serious Lower GI Events per
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This text was captured on Apr 08, 2017 Show All Captures
Pfizer June 15 3 Introduction i Placebo-controlled CV outcome studies in hypertensive patients are no longer ethical i ALLHAT can be considered a well-conducted, large, randomized, double-blind, active-controlled
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URL: https://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4090OPH1_08_Eisner_files/slide0042.htm
This text was captured on Apr 08, 2017 Show All Captures
pfizer capsule study 12 · As in the upper GI tract, inhibition of COX-1 by naproxen and not celecoxib translates into significantly different rates of mucosal injury in the small bowel · These findings
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URL: https://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4235S1-02-01-PfizerInc_files/slide1181.htm
This text was captured on Apr 07, 2017 Show All Captures
Pfizer Slides - Fragmin 11 i Association of VTE and cancer first noted by Trousseau in 1865 i 4 to 7-fold increase in risk of venous thrombosis in cancer patients i The estimated annual incidence of VTE
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URL: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm208976.htm
This text was captured on Jan 12, 2017 Show All Captures
This additional information/language was not approved by the IRB/IEC and Pfizer . 3.
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URL: https://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4235S1-02-01-PfizerInc_files/slide1208.htm
This text was captured on Apr 07, 2017 Show All Captures
Pfizer Slides - Fragmin 45 * 1 fatal PE in dalteparin and 1 fatal PE in OAC occurred after a previous PE and so were not counted as a fatal PE endpoint ** 2 cases in dalteparin group and 1 case in OAC
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URL: https://www.fda.gov/ICECI/CriminalInvestigations/ucm255942.htm
This text was captured on Apr 05, 2017 Show All Captures
Date Posted: May 19, 2011 Pfizer and its Greenstone subsidiary are working with the U.S.
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URL: https://www.fda.gov/Drugs/DrugSafety/ucm563378.htm
This text was captured on Jul 25, 2018 Show All Captures
For additional information, health care professionals can also contact Pfizer directly.
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URL: http://www.fda.gov/ICECI/CriminalInvestigations/ucm255942.htm
This text was captured on Jan 11, 2017 Show All Captures
Date Posted: May 19, 2011 Pfizer and its Greenstone subsidiary are working with the U.S.
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This text was captured on Dec 20, 2020 Show All Captures
Q: How well does Pfizer -BioNTech COVID-19 Vaccine prevent COVID-19?
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URL: https://www.fda.gov/Safety/Recalls/ArchiveRecalls/2010/ucm237938.htm
This text was captured on Apr 04, 2017 Show All Captures
Pfizer To Recall One Lot Of Lipitor In The U.S.
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URL: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108792.htm
This text was captured on Jan 12, 2017 Show All Captures
This independent board notified Pfizer of the mortality finding early the morning of December 2, 2006 and FDA was notified at 4:00 PM EST that evening that Pfizer planned to halt this trial and the development
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This text was captured on Dec 17, 2020 Show All Captures
Emergency Use Authorization Status: Authorized Name: Pfizer -BioNTech COVID-19 Vaccine Manufacturer: Pfizer Inc.
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URL: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm216448.htm
This text was captured on Jan 14, 2017 Show All Captures
FDA: Pfizer Voluntarily Withdraws Cancer Treatment Mylotarg from U.S.
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URL: https://www.fda.gov/Safety/Recalls/ArchiveRecalls/2010/ucm227658.htm
This text was captured on Apr 06, 2017 Show All Captures
Pfizer Consumer Healthcare Issues Voluntary Recall of One Lot of ThermaCare HeatWraps Menstrual Product FOR IMMEDIATE RELEASE – September 24, 2010 – Madison, NJ – Pfizer Consumer Healthcare, a business
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URL: https://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm563360.htm
This text was captured on Apr 22, 2019 Show All Captures
Extended Use Dates Provided by Pfizer Skip to main page content Skip to search Skip to topics menu Skip to common links HHS U.S. Department of Health and Human Services U.S.
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URL: http://www.fda.gov/Safety/Recalls/ucm241070.htm
This text was captured on Jan 13, 2017 Show All Captures
RELISTOR KIT PACKAGING Pfizer Contact: Rick Chambers (269) 833-6387 Progenics Contact: Amy Martini (914) 789-2816 FOR IMMEDIATE RELEASE - January 25, 2011 - NEW YORK, N.Y. and TARRYTOWN, N.Y. – Pfizer
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