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Structured Product Labeling
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71	Guidance for Industry Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act DRAFT GUIDANCE Add to Reading List Source URL: www.fda.gov. Language: English Pharmaceutical sciences Pharmaceuticals policy Pharmacology Pharmaceutical industry Food law Structured Product Labeling National Drug Code Federal Food Drug and Cosmetic Act Good manufacturing practice Health Food and Drug Administration Medicine
72	FDA Regional Technical Specifications for ICH E2B (R3) Implementation Postmarket Submission of Individual Case Safety Reports (ICSRs) for Vaccines Draft Technical Specifications Document This Document is incorporated by Add to Reading List Source URL: www.fda.gov Language: English Research Drug safety Medical informatics Clinical research Clinical Data Management Vaccine Adverse Event Reporting System Structured Product Labeling Electronic Common Technical Document Adverse Event Reporting System Medicine Food and Drug Administration Health
73	FDA Data Standards: An Update Lilliam Rosario, Ph.D. Associate Director Office of Critical Path Programs Add to Reading List Source URL: www.fda.gov Language: English Science Health informatics Standards organizations International standards Drug Information Association Food and Drug Administration Health Level 7 Structured Product Labeling Data mining Health Medical informatics Medicine
74	Guidance for Industry Accelerated Approval Products — Submission of Promotional Materials DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Biologic FDA Fast Track Development Program Federal Food Drug and Cosmetic Act Prescription Drug User Fee Act Structured Product Labeling Food and Drug Administration Medicine Health
75	Guidanc Providing Regulatory Su Electronic Format Labelin, issions in Add to Reading List Source URL: www.fda.gov Language: English - Date: 2005-04-19 11:19:06 Medical informatics Pharmaceuticals policy Pharmaceutical industry Health informatics Structured Product Labeling Health Level 7 Daily Med Title 21 CFR Part 11 New Drug Application Food and Drug Administration Medicine Health
76	Script - An Introduction to the Improved FDA Prescription Drug Labeling Welcome and thank you for participating in the Food and Drug Administration, Center for Drug Evaluation and Research continuing education activity Add to Reading List Source URL: www.fda.gov. Language: English Pharmacology Food and Drug Administration Pharmaceutical industry Medical informatics Piperazines Package insert Structured Product Labeling Adverse effect Norfloxacin Medicine Health Pharmaceutical sciences
77	PDF Document Add to Reading List Source URL: www.fda.gov Language: English - Date: 2000-11-15 00:43:22 Emergency contraception Pharmaceutical Research and Manufacturers of America Combined oral contraceptive pill Package insert Birth control Norfloxacin Beyaz Structured Product Labeling Hormonal contraception Medicine Technology
78	PDF Document Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-12-24 14:49:00 Drug safety Clinical pharmacology Food and Drug Administration Therapeutics United States Public Health Service Over-the-counter drug Dietary supplement Cosmetics Structured Product Labeling Pharmacology Medicine Pharmaceutical sciences
79	Microsoft Word - 7074fnl.doc Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Pharmaceutical industry Structured Product Labeling Clinical research Drug safety New Drug Application Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Health Level 7 Medicine Medical informatics Health
80	101Cornegie Center Princeton,New Jersey[removed]USA November 16,2006 Division of Documents Management (HFA-305) Add to Reading List Source URL: www.fda.gov Language: English - Date: 2007-01-12 17:12:15 Food and Drug Administration Clinical pharmacology Therapeutics United States Public Health Service Structured Product Labeling National Drug Code Pharmaceutical sciences Pharmacology Medicine

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