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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Requirements for Decontamination by Autoclaving

Revised 4-3-2012 EHS Biosafety 2 Place clear autoclave bag or other container in a SECONDARY container suitable for autoclaving. labeled with a biohazard symbol/sticker . d. a. Make sure your plastic secondary container is Not all plastics can be

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THERAPEUTIC RESOURCE

VIRKON 1% solutions are stable for 7 days but should be discarded when the pink colour fades. Certification Product is registered in accordance with the requirements

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at of 35 43 ENT UK London WC2A 3PE - Tristel

2 Guidance on the decontamination and sterilization of rigid and flexible endoscopes Key Recommendations 1 Following rigid and flexible endoscopy of the nose and throat, the endoscope will

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Infection prevention and control principles and ...

Infection prevention and control principles and recommendations for Ebola virus disease . Including information about personal protective equipment for clinical care of patients with suspected

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A GUIDELINE FOR THE SAFE USE OF AUTOCLAVES

A GUIDELINE FOR THE SAFE USE OF AUTOCLAVES UNIVERSITY OF OTTAWA Environmental Health and Safety Service Last date of revision July 9, 2003

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Inspection Checklist for BSL-3 Laboratories (7 CFR 331; 9 ...

BSL3 – 6 Entity Name: Inspection Date: Reference Statement Yes No N/A Comments BMBL: A11 Personnel must receive annual updates or additional training when procedural or policy changes occur. BMBL: A11 Personal health status may impact an individual?s susceptibility to infection, ability to receive immunizations or prophylactic