BCG Vaccine Package Insert - Food and Drug Administration

eSubmitter Quick Guide - Food and Drug …

Allows you to create a new submission entry. The New Submission Data Dialog box will ap-pear. See section Creating a New Submission for more detailed information.

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1 APPENDIX B - PRODUCT NAME SORTED BY …

june 2018 - approved drug product list b - 2 appendix b - product name sorted by applicant ** a ** * abbvie inc norvir, ritonavir technivie, ombitasvir

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Study Data Specifications - Food and Drug …

Study Data Specifications STUDY DATA SPECIFICATIONS . These specifications are for submitting animal and human study datasets in electronic format.

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Sanofi Pasteur 20 April 2016v0.2 095 - ActHIB LE6940

Sanofi Pasteur 20 April 2016v0.2 095 - ActHIB® LE6940 Confidential/Propietary Information Page 2 of 19 1 . FULL PRESCRIBING INFORMATION: 2 . …

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Repackaging of Certain Human Drug Products by …

Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities. Guidance for Industry . Additional copies are available from: Office of …

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POLICY AND PROCEDURES OFFICE OF …

MANUAL OF POLICIES AND PROCEDURES CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 5040.1 Originating Office: Office of Pharmaceutical Quality Effective Date: 5/24/2004; 2/26/2014, 01/26/2017 Page 1 of 9

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BIORESEARCH MONITORING TECHNICAL …

BIORESEARCH MONITORING TECHNICAL CONFORMANCE GUIDE Containing Technical Specifications For questions regarding …

Guidance for Industry - Food and Drug …

Guidance for Industry . Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening

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TABLE OF CONTENTS - Food and Drug …

List of Abbreviations Used . General Abbreviations . AR Antimicrobial Resistance . BAP Blood Agar Plate . CCA Campy-Cefex Agar Plate . CDC Centers for …

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148 COAGULA BeneF D RECOMBINANT W IX TION …

procedures was 85 ± , Coagulation Factor IX (Recombinant), is indicated for the control and ). Patients with factor IX inhibitors may be at an increased risk of

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Package Insert - T-SPOT.com

T-SPOT.TB Package Insert PI-TB-US-V5 Page 3 of 36 1. INTENDED USE The T-SPOT®.TB test is an in vitro diagnostic test for the detection of effector T cells that respond to stimulation by Mycobacterium tuberculosis antigens ESAT-6 and CFP 10 by capturing interferon gamma (IFN- ) in the vicinity of T cells in human whole blood collected in sodium citrate or sodium or lithium heparin.

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MEDICATION GUIDE STELARA (stel ar’ a) (ustekinumab ...

2 STELARA® (ustekinumab) Before you receive STELARA, tell your doctor about all of your medical conditions, including if you: • have any of the conditions or symptoms listed in the section “What is the most important information I should know about STELARA?” • ever had an allergic reaction to STELARA.

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TREMFYA (trem fye´ ah) (guselkumab) injection, for ...

Medication Guide TREMFYA® (trem fye´ ah) (guselkumab) injection, for subcutaneous use What is the most important information I should know about TREMFYA? …

Cepheid Xpert MTB/RIF assay in making decisions to ...

GENEXPERT IN A.I.I. DISCHARGE DECISIONS 1 NTCA APHL | APRIL, 2016 Consensus statement on the use of Cepheid Xpert MTB/RIF® assay in making decisions to discontinue airborne infection isolation in healthcare settings PURPOSE The purpose of this consensus statement is to provide

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HIGHLIGHTS OF PRESCRIBING INFORMATION • Patients ...

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ORENCIA safely and effectively. See full prescribing information for ORENCIA.

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1 of 56 - Food and Drug Administration

lymphoma, have been reported in patients treated with TNF blockers including infliximab products. These cases have had a very aggressive disease course and have been fatal.

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QuantiFERON -TB Gold Plus

1107787 07/2017 To find out more about QuantiFERON-TB Gold Plus, visit www.QuantiFERON.com or contact your local QFT-Plus sales representative. QFT-Plus is an in vitro diagnostic aid for detection of Mycobacterium tuberculosis infection. It uses a peptide cocktail simulating ESAT-6