Drug Master File - PDFSEARCH.IO - Document Search Engine

Drug Master File
Results: 255

#	Item
211	EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Add to Reading List Source URL: www.nmvrvi.lt Language: English - Date: 2012-12-13 15:43:53 Pharmacology Health Drug safety Pharmacy European Medicines Agency Qualified Person for Pharmacovigilance Drug Master File Marketing authorization Test data exclusivity Pharmaceutical sciences Pharmaceutical industry Pharmaceuticals policy
212	API Focussed MHRA Inspections at Dosage Form Manufacturers Add to Reading List Source URL: www.mhra.gov.uk Language: English - Date: 2010-06-17 10:20:57 Pharmacology Good manufacturing practice Medicines and Healthcare products Regulatory Agency Drug Master File European Medicines Agency Audit Quality management system Application programming interface Pharmaceutical industry Pharmaceutics Pharmaceutical sciences
213	CBER Master Section: CBER ADMIN Welcome DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION Add to Reading List Source URL: www.fda.gov Language: English Computer file formats ISO standards Open formats Standard Generalized Markup Language Document Type Definition XML Portable Document Format Comma-separated values Computing Markup languages Technical communication
214	DRUG MASTER FILES UNDER GDUFA: DMF Basics Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Medicine Health Clinical research Drug Master File Drug safety Electronic Common Technical Document New Drug Application Prescription Drug User Fee Act Pharmaceuticals policy Pharmaceutical industry Food and Drug Administration
215	Microsoft Word - 10535fnl[removed]doc Add to Reading List Source URL: www.fda.gov Language: English Pharmaceuticals policy Medicine Health Clinical research Pharmacology New Drug Application Drug Master File Investigational New Drug Regulatory requirement Pharmaceutical industry Pharmaceutical sciences Food and Drug Administration
216	Microsoft Word - 6255dft.doc Add to Reading List Source URL: www.fda.gov Language: English Health Clinical research Interventional cardiology Drug safety Investigational Device Exemption Drug Master File Drug-eluting stent Premarket approval New Drug Application Medicine Food and Drug Administration Pharmaceutical industry
217	Guidance for Industry NDAs: Impurities in Drug Substances U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Clinical research Clinical pharmacology Abbreviated New Drug Application Center for Drug Evaluation and Research New Drug Application New chemical entity Drug Master File Biologic Pharmaceutical sciences Pharmaceutical industry Pharmacology
218	Guidance for Industry Changes to an Approved NDA or ANDA Questions and Answers 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 Food law Drug Master File New Drug Application Good manufacturing practice Center for Drug Evaluation and Research Pharmaceutical industry Food and Drug Administration Pharmaceutical sciences
219	Guidance for Industry Submitting Debarment Certification Statements DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be s Add to Reading List Source URL: www.fda.gov Language: English Health Pharmaceutical sciences Clinical research Drug safety Pharmaceuticals policy Debarment New Drug Application Investigational New Drug Drug Master File Food and Drug Administration Medicine Pharmaceutical industry
220	GUIDELINE FOR SUBMITTING SUPPORTING DOCUMENTATION IN DRUG APPLICATIONS FOR THE MANUFACTURE OF DRUG SUBSTANCES Center for Drug Evaluation and Research Food and Drug Administration Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Chemistry Medicinal chemistry Drug Master File Chemical substance Natural product Drug discovery Lysergic acid diethylamide Methamphetamine Pharmaceutical sciences Pharmacology Medicine

UPDATE