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Drug Master File
Results: 255

#	Item
161	Microsoft Word - IPEC Meeting Minutes_120911_Final.doc Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutics Drug Master File Food and Drug Administration Generic drug New Drug Application Pharmaceutical industry Pharmaceutical sciences Pharmacology
162	Thomas Hinchliffe, Pharm.D. CDR, U.S. Public Health Service Special Assistant to the Director Office of Generic Drugs Food and Drug Administration Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutics Food and Drug Administration Generic drug New Drug Application Drug Master File Anda Pharmaceutical industry Pharmaceutical sciences Pharmacology
163	Progress Update: Health Canada's Use of the European Directorate for the Quality of Medicines and Healthcare's Certificate of Suitability and the Signing of a Memorandum of Understanding Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-07-12 14:25:43 Pharmacology Medicine Pharmaceutical industry Clinical research European Directorate for the Quality of Medicines Strasbourg Therapeutic Products Directorate Drug Master File European Pharmacopoeia Council of Europe Health Canada Pharmaceutical sciences
164	Guidance for Industry Analytical Procedures and Methods Validation Chemistry, Manufacturing, and Controls Documentation DRAFT GUIDANCE Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutics Medicine Clinical research Validity Food safety Validation Verification and validation Drug Master File New Drug Application Pharmaceutical industry Pharmaceutical sciences Food and Drug Administration
165	Department of Health and Human Services Food and Drug Administration COMMON EMEA / FDA APPLICATION FOR ORPHAN MEDICINAL PRODUCT DESIGNATION Add to Reading List Source URL: www.fda.gov Language: English Pharmaceuticals policy Food and Drug Administration Pharmaceutical industry Clinical research United States Public Health Service European Medicines Agency Orphan drug Federal Food Drug and Cosmetic Act Drug Master File Pharmaceutical sciences Health Pharmacology
166	DMFs from a GDUFA Perspective David Skanchy, Ph.D. Director DMF Review Staff/OGD June 2013 Introduction to New GDUFA Requirements Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Filing Fee Pharmacology Drug Master File Pharmaceutical sciences Clinical research Abbreviated New Drug Application
167	DOC Document Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2014-01-30 13:34:04 Drug Master File Dosage form Dose Abbreviated New Drug Application Pharmacy Pharmaceuticals policy Pharmaceutical industry Pharmaceutical sciences Pharmacology
168	Microsoft Word - pdf cpidce_temp_mod_dcipec-eng.docx Add to Reading List Source URL: www.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
169	DRUG MASTER FILES UNDER GDUFA: DMF Basics Arthur B. Shaw, Ph.D. DMF Expert FDA Add to Reading List Source URL: www.fda.gov Language: English Medicine Pharmaceutical sciences Health Clinical research Drug Master File Drug safety New Drug Application Electronic Common Technical Document Generic drug Food and Drug Administration Pharmaceutical industry Pharmaceuticals policy
170	User Fees Donal Parks, MBA, MPM Director User Fee Collections Staff Office of Management Add to Reading List Source URL: www.fda.gov Language: English Prescription Drug User Fee Act Fee Abbreviated New Drug Application Patent application User fee Credit card Anda Business Taxation in the United States Drug Master File Pharmaceutical industry

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