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Drug Master File
Results: 255

#	Item
151	Optimizing your eCTD ANDA Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Clinical Data Management Medical informatics Drug safety Electronic Common Technical Document International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Drug Master File Abbreviated New Drug Application Food and Drug Administration Clinical research Research Medicine
152	Field 29 of the 356h Form Francis Godwin Branch Chief Generic Drug Manufacturing Assessment Branch Division of Good Manufacturing Practice Assessment Office of Manufacturing and Product Quality Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmaceutics Food and Drug Administration Clinical research Drug safety New Drug Application Good manufacturing practice Generic drug Drug Master File Pharmaceutical industry Pharmaceutical sciences Pharmaceuticals policy
153	IID Team Minutes[removed]May 17 - IPEC Meeting with FDA-OGD FINAL_KU_MR 1 Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Clinical pharmacology Food and Drug Administration Therapeutics United States Public Health Service Drug Master File Spreadsheet Pharmaceutical sciences Pharmaceutical industry Clinical research
154	Microsoft Word - PDF cpidce_guide_ld_dcipec-eng.doc Add to Reading List Source URL: www.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
155	Issued: [removed]Guidance for Industry: Content and Format of Chemistry, Add to Reading List Source URL: www.fda.gov Language: English Anatomy Immune system Immunology Quality Pharmacology Allergen Validation Patch test Drug Master File Medicine Health Pharmaceutical industry
156	Draft Guidance Document - Preparatin of Drug Regulatory Activities in the Electronic Common Technical Document Format Add to Reading List Source URL: www.hc-sc.gc.ca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
157	Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) Add to Reading List Source URL: www.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
158	Huyi Zhang, Ph.D. DMF Review Staff, OGD Completeness Assessment for Type II Active Pharmaceutical Ingredient Drug Master Files Add to Reading List Source URL: www.fda.gov Language: English Health Drug Master File Food and Drug Administration Pharmaceuticals policy Abbreviated New Drug Application Federal Food Drug and Cosmetic Act Anda Pharmaceutical sciences Pharmaceutical industry Medicine
159	Microsoft Word - ctd_prep_rev_nds-eng.doc Add to Reading List Source URL: www.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
160	Guidance for Industry Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Investigational New Drug New Drug Application Drug Master File Federal Food Drug and Cosmetic Act Center for Biologics Evaluation and Research Dietary supplement Prescription Drug User Fee Act Pharmaceutical industry Food and Drug Administration Medicine Health

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