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Drug Master File
Results: 255

#	Item
51	Guidance for Industry Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies Add to Reading List Source URL: www.fda.gov Language: English Health Clinical research Interventional cardiology Drug safety Investigational Device Exemption Drug Master File Drug-eluting stent Premarket approval New Drug Application Medicine Food and Drug Administration Pharmaceutical industry
52	Version July[removed]PROTECTED ` Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2013-06-24 11:49:04 Pharmaceutical sciences Pharmacology Validity Food and Drug Administration Validation Abbreviated New Drug Application Clinical trial Drug Master File Methamphetamine Pharmaceutical industry Clinical research Pharmaceutics
53	Pharmaceutical company and (Drug) Master File in Japan The Second China - Japan Symposium April 29th 2011, Beijing Add to Reading List Source URL: www.pmda.go.jp Language: English - Date: 2011-04-13 02:42:38 Deng Jiaxian Zhang Zhaohuan
54	Version July 2012 PROTECTED VETERINARY DRUGS DIRECTORATE (VDD) Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2013-06-24 11:48:35 Pharmaceuticals policy Business Evaluation Product development Specification Technical communication Generic drug Validation Drug Master File Pharmaceutical industry Quality Technology
55	Microsoft Word - ctd_prep_rev_nds-eng.doc Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2014-06-17 11:30:03 Research Technology Pharmaceutical industry Medical informatics Electronic Common Technical Document Common Technical Document Global Harmonization Task Force Drug Master File Clinical trial Medicine Clinical research Clinical Data Management
56	Microsoft Word - int_drug_list_notice_avis_proc_int_exam-eng.docx Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2013-06-24 11:49:33 Screening Drug Master File Generic drug Drug discovery Electronic submission Pharmaceutical sciences Pharmaceutical industry Pharmacology
57	Version July 2012 PROTECTED ` VETERINARY DRUGS DIRECTORATE (VDD) Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2013-06-24 11:48:35 Technology Clinical research Quality Pharmacology Validity Validation Excipient Drug Master File Bioavailability Pharmaceutical industry Pharmaceutical sciences Science
58	Master File System for Drug Substances, etc. 1. Master File (MF) System Master file (hereinafter referred to as “MF”) system for drug substances, etc. allows Japanese or foreign manufacturers of drug substances etc. Add to Reading List Source URL: www.pmda.go.jp Language: English - Date: 2013-06-09 22:47:17 Health Pharmaceutical industry Marketing authorization Generic drug Over-the-counter drug Clinical trial Medical prescription Pharmaceutical sciences Pharmaceuticals policy Pharmacology
59	ACCOUNTABILITY REPORT MASTER FILE Add to Reading List Source URL: www.scstatehouse.gov Language: English - Date: 2012-09-24 11:27:56 United States Department of Health and Human Services Health policy Government Center for Substance Abuse Treatment Health California Department of Alcohol and Drug Programs Substance Abuse and Mental Health Services Administration Medicaid Best practice
60	INSTRUCTIONS FOR FILLING OUT FORM FDA 356h – APPLICATION TO MARKET A NEW OR ABBREVIATED NEW DRUG OR BIOLOGIC FOR HUMAN USE (The field numbers below correspond to the numbered boxes on the Form FDA 356h) NOTE: Please Add to Reading List Source URL: www.fda.gov. Language: English Medicine Drug safety Health Clinical research New Drug Application Investigational New Drug Biologic License Application Drug Master File Food and Drug Administration Pharmaceutical industry Pharmaceutical sciences