POLICY AND PROCEDURES OFFICE OF NEW DRUGS …
MANUAL OF POLICIES AND PROCEDURES CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 6030.1 Rev. 3 Originating Office: Office of New Drugs Effective Date: 11/20/95; 6/20/96; 5/1/98; 02/20/2018 Page 2 of 9
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POLICY AND PROCEDURES OFFICE OF …
www.fda.govMANUAL 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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Repackaging of Certain Human Drug Products by …
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148 COAGULA BeneF D RECOMBINANT W IX TION …
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eSubmitter Quick Guide - Food and Drug …
www.fda.govAllows 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 …
www.fda.govjune 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 …
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Sanofi Pasteur 20 April 2016v0.2 095 - ActHIB LE6940
www.fda.govSanofi Pasteur 20 April 2016v0.2 095 - ActHIB® LE6940 Confidential/Propietary Information Page 2 of 19 1 . FULL PRESCRIBING INFORMATION: 2 . …
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www.fda.govBIORESEARCH MONITORING TECHNICAL CONFORMANCE GUIDE Containing Technical Specifications For questions regarding …
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