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Drug Master File
Results: 255

#	Item
241	Completeness Assessment for Type II Active Pharmaceutical Ingredient Drug Master Files to Be Referenced in ANDAs Add to Reading List Source URL: www.fda.gov Language: English Clinical research Drug Master File Generic drug Abbreviated New Drug Application Food and Drug Administration Active ingredient Pharmaceutical sciences Pharmacology Pharmaceutical industry
242	Microsoft Word - Variation Type IA and IB guideline rev.1 5 July[removed]doc Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-09 08:55:19 Validation Drug Master File Qualified Person Good manufacturing practice Health Science Business Pharmaceutical industry Clinical research Pharmaceuticals policy
243	Common Incomplete Comments Observed in Completeness Assessment of Type II API DMF Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Food and Drug Administration Therapeutics United States Public Health Service Manufacturing Pharmaceutical industry Drug Master File Pharmaceutical sciences Clinical research Clinical pharmacology
244	Guidance for Industry ANDA Submissions — Amendments and Easily Correctable Deficiencies Under GDUFA DRAFT GUIDANCE Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Medicine Health Prescription Drug User Fee Act New Drug Application Generic drug Federal Food Drug and Cosmetic Act United States Bill of Rights Drug Master File Food and Drug Administration Pharmaceuticals policy Pharmaceutical industry
245	57 MASTER FILES Guidance for Industry for the Preparation and Submission of Veterinary Master Files Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Medicine Clinical research Drug Master File Center for Veterinary Medicine Validation Computer file Federal Food Drug and Cosmetic Act Pharmaceutical sciences Pharmaceutical industry Food and Drug Administration
246	EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE GENERAL Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2014-01-31 02:57:55 Health Pharmacology Clinical research Drug safety European Medicines Agency Drug Master File Marketing authorization CE mark Test data exclusivity Pharmaceuticals policy Pharmaceutical sciences Pharmaceutical industry
247	DOC Document Add to Reading List Source URL: www.hma.eu Language: English - Date: 2014-06-13 11:13:48 Marketing authorization Validation Qualified Person for Pharmacovigilance Drug Master File Pharmaceutical industry Pharmaceutical sciences Pharmacology
248	Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.seikiken.or.jp Language: English - Date: 2014-03-14 03:27:13 Research Medicine Clinical research Pharmacology Drug safety Validation Center for Biologics Evaluation and Research Drug Master File Biologic Food and Drug Administration Pharmaceutical industry Pharmaceutical sciences
249	ACCOUNTABILITY REPORT MASTER FILE Add to Reading List Source URL: www.daodas.state.sc.us Language: English - Date: 2013-10-17 16:02:46 Substance Abuse and Mental Health Services Administration United States Department of Health and Human Services Best practice Health care provider Center for Substance Abuse Treatment California Department of Alcohol and Drug Programs Health Medicine Substance abuse
250	Contacts: Neuland Laboratories Ltd. Swathi Kuricheti Communications Officer +[removed] Add to Reading List Source URL: www.neulandlabs.com Language: English - Date: 2013-10-17 03:37:23 Pharmaceutics Food safety Good manufacturing practice Pharmaceuticals policy Drug Master File Neuland Food and Drug Administration Contract manufacturing organization Form FDA 483 Pharmaceutical industry Pharmaceutical sciences Pharmacology

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