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Drug Master File
Results: 255

#	Item
71	Approaches to GMP inspection Add to Reading List Source URL: www.fda.gov Language: English Pharmaceuticals policy Health Food and Drug Administration Therapeutics United States Public Health Service Abbreviated New Drug Application Quality management system Good manufacturing practice Drug Master File Pharmaceutical sciences Pharmaceutical industry Pharmacology
72	LETTER OF AUTHORIZATION (LOA) No Cover (Transmittal) Letter necessary Notes are in bold font. Information to be filled in is in italics Add to Reading List Source URL: www.fda.gov Language: English Drug safety Medicine Pharmacology Drug Master File Clinical research New Drug Application Investigational New Drug Pharmaceutical industry Pharmaceutical sciences Food and Drug Administration
73	of Health and Human Services Food dnd Drug Administration Center for Drug Evaluation and Research (CDER) Dockets Management Branch (HFA[removed]docket no. OOD[removed]Fishers Lane Add to Reading List Source URL: www.fda.gov Language: English - Date: 2000-10-26 13:05:55 Health Herbalism Alternative medicine Active ingredient Food and Drug Administration Pharmaceutical drug Dietary supplement Phytotherapy Drug Master File Pharmaceutical sciences Pharmacology Medicine
74	April 19,2005 Via fax and UPS Division of Dockets Management (HFA-305) m -.....‘ and Drug Administration Add to Reading List Source URL: www.fda.gov Language: English - Date: 2005-05-03 15:05:35 Clinical research Food and Drug Administration Drug Master File Abbreviated New Drug Application Impurity New Drug Application Pharmaceutical drug Monograph Pharmaceutical industry Pharmaceutical sciences Pharmacology
75	1680 STEWART AVENUE, WESTBURY, NY lf590[removed] * FAX (5X6) au-1887 anagement Branch Food and Drug Ad~i~istratjo~ (HFA[removed]Fishers Lane Add to Reading List Source URL: www.fda.gov Language: English - Date: 2001-12-19 09:35:00 Pharmacology Research Food and Drug Administration Clinical research Abbreviated New Drug Application Generic drug Approved drug New Drug Application Drug Master File Pharmaceutical industry Pharmaceutical sciences Pharmaceuticals policy
76	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: 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
77	DOC Document Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-12-24 14:47:11 Pharmacology Drug Master File Validation Good manufacturing practice Food and Drug Administration Communications protocol Pharmaceutical industry Pharmaceutical sciences Pharmaceutics
78	Guidance for Industry ANDAs: Impurities in Drug Substances DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.fda.gov Language: English - Date: 2005-01-27 12:56:56 Impurity Materials Clinical research Drug Master File Science Food and Drug Administration Abbreviated New Drug Application Chemical substance Pharmaceutical sciences Pharmaceutical industry Environmental chemistry
79	October 19,2004 Suite[removed]Bethesda Metro Center Bethesda, MD[removed]USA Tel: +I[removed]Fax: +I[removed] Add to Reading List Source URL: www.fda.gov Language: English - Date: 2004-11-18 17:02:26 Clinical research Science Research Pharmacology Pharmaceuticals policy Chromatography Drug Master File Validation New Drug Application Pharmaceutical industry Pharmaceutical sciences Food and Drug Administration
80	Via Courier October[removed]Dockets Management Branch (HFA-305) Food and Drug Administration Room[removed]Fishers Lane Add to Reading List Source URL: www.fda.gov Language: English - Date: 2000-10-26 13:05:35 Medicine Clinical research Pharmaceuticals policy Food and Drug Administration New Drug Application Drug Master File Over-the-counter drug Good manufacturing practice Dietary supplement Pharmaceutical sciences Pharmaceutical industry Pharmacology

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