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Drug Master File
Results: 255

#	Item
81	Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics CHEMISTRY, MANUFACTURING, AND CONTROLS DOCUMENTATION U.S. Department of Health and Human Services Add to Reading List Source URL: www.fda.gov Language: English Medicine Health Pharmaceuticals policy Clinical research Pharmacology Drug Master File Packaging and labeling Center for Biologics Evaluation and Research Biologic Pharmaceutical industry Food and Drug Administration Pharmaceutical sciences
82	Microsoft Word - PDF cpidce_guide_ld_dcipec-eng.doc Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2014-01-24 13:14:11 Eli Lilly and Company Chemistry Technology Clinical research Quality Validation Packaging and labeling Drug Master File Abbreviated New Drug Application Pharmaceutical industry Pharmacology Pharmaceutical sciences
83	: * DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Add to Reading List Source URL: www.fda.gov Language: English - Date: 2005-10-03 11:00:43 Pharmaceutics Food and Drug Administration Drug Master File Generic drug Abbreviated New Drug Application New Drug Application Monograph Substance abuse Pharmaceutical industry Pharmaceutical sciences Pharmacology
84	Guidance for Industry ANDAs: Impurities in Drug Substances U.S. Department of Health and Human Services Food and Drug Administration Add to Reading List Source URL: www.fda.gov Language: English - Date: 2005-10-03 11:00:43 Pharmaceutical industry Environmental chemistry Impurity Materials Drug Master File Chemical substance Drug reference standard Methamphetamine Food and Drug Administration Pharmacology Pharmaceutical sciences Medicine
85	; DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1998D-O514] Draft Guidance for Industry on Abbreviated Add to Reading List Source URL: www.fda.gov Language: English - Date: 2005-01-27 12:30:54 Pharmacology Drug Master File Food and Drug Administration Abbreviated New Drug Application Pharmaceutical sciences Clinical research Pharmaceutical industry
86	4“”0 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98 D[removed]Draft Guidance for Industry on ANDA’s: Impurities in Drug Substances; Availability; Reopening of Comment Period Add to Reading List Source URL: www.fda.gov Language: English - Date: 2005-10-03 11:00:44 Pharmacology Clinical research Food and Drug Administration Therapeutics Drug Master File Generic drug Pharmaceutical industry Pharmaceutical sciences Pharmaceuticals policy
87	Draft Guidance Document - Preparatin of Drug Regulatory Activities in the Electronic Common Technical Document Format Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2013-07-09 17:16:48 Technology Clinical Data Management Pharmaceutical industry Pharmaceuticals policy Drug safety Electronic Common Technical Document Common Technical Document International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Drug Master File Medicine Clinical research Research
88	Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2014-01-27 10:17:23 Pharmaceutical sciences clinical research Pharmacology Drug safety Drug Master File Common Technical Document Regulatory requirement Validation Regulation of therapeutic goods Pharmaceuticals policy Pharmaceutical industry Medicine
89	Microsoft Word - pdf cpidce_temp_mod_dcipec-eng.docx Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2014-01-24 13:14:11 Drug Master File Abbreviated New Drug Application Dosage form Dose Pharmacy Pharmaceuticals policy Pharmaceutical industry Pharmaceutical sciences Pharmacology
90	Microsoft PowerPoint - GCG2008 Beijing Hiyama Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-22 04:06:39 Marketing authorization Technology Drug Master File Q Specification Business Television in the United Kingdom Pharmaceutical industry Pharmaceuticals policy Quality