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Drug user
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481	RTF Document Add to Reading List Source URL: www.fda.gov Language: English - Date: 2002-09-18 17:34:54 Pharmacology Health Pharmaceuticals policy Pharmaceutical industry Drug safety New Drug Application Prescription Drug User Fee Act Pharmacovigilance Rosiglitazone Pharmaceutical sciences Food and Drug Administration Medicine
482	APPENDIX E DEVELOPMENT OF COSTS FOR THE PROCESS FOR THE REVIEW OF MEDICAL DEVICE APPLICATIONS GENERAL METHODOLOGY The costs associated with the process for the review of medical device applications are based on Add to Reading List Source URL: www.fda.gov Language: English Center for Devices and Radiological Health Center for Biologics Evaluation and Research Prescription Drug User Fee Act Medical device Indirect costs Office of Regulatory Affairs Cost Premarket approval Food and Drug Administration Medicine Health
483	BACKGROUND The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by MDUFA, authorizes FDA to collect fees from the medical device industry to augment appropriations spent on FDA’s medical device review proces Add to Reading List Source URL: www.fda.gov Language: English Technology Federal Food Drug and Cosmetic Act Premarket approval Medical device Food and Drug Administration Modernization Act Prescription Drug User Fee Act Medicine Food and Drug Administration Health
484	TOTAL COSTS OF THE PROCESS FOR THE REVIEW OF MEDICAL DEVICE APPLICATIONS Table 7 shows the costs for the review of medical device applications during the past two fiscal years by FDA organizational component. It depicts Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Center for Devices and Radiological Health Medical device Center for Biologics Evaluation and Research Prescription Drug User Fee Act Medicine Food and Drug Administration Health
485	MADIT-CRT Panel Package Circulatory Systems Panel Meeting for March 18, 2010 P010012/S230 Expanded User Labeling Including Indications Below is the list of contents in this panel packet. A suggested area of focus for rev Add to Reading List Source URL: www.fda.gov Language: English Cardiac electrophysiology Implanted cardiac resynchronization device Food and Drug Administration Tab key Medicinal chemistry Pharmaceutical sciences Clinical research Pharmacology
486	MEETING THE LEGAL CONDITIONS FOR USER FEES IN FY 2012 MDUFA imposes three legal conditions that FDA must satisfy annually for the agency to be able to collect and spend medical device user fees. A summary of how each of Add to Reading List Source URL: www.fda.gov Language: English Clinical pharmacology Food and Drug Administration Pharmacology Therapeutics United States Public Health Service Medical device Medicine Health Pharmaceutical sciences
487	MANAGEMENT CHALLENGES FOR FY 2013 To meet the demanding review time goals established under AGDUFA in FY 2013, FDA will be challenged to: • • • Add to Reading List Source URL: www.fda.gov Language: English Clinical pharmacology Food and Drug Administration Therapeutics United States Public Health Service Prescription Drug User Fee Act Abbreviated New Drug Application Pharmaceutical sciences Clinical research Pharmacology
488	FY 2012 AGDUFA FINANCIAL REPORT REQUIRED BY THE ANIMAL GENERIC DRUG USER FEE ACT Add to Reading List Source URL: www.fda.gov Language: English Health Food and Drug Administration Food law Pharmaceutical industry Generic drug Federal Food Drug and Cosmetic Act Fee Prescription Drug User Fee Act Pharmaceutical sciences Pharmaceuticals policy Pharmacology
489	AGDUFA-FY-2011-Revised-Final[removed]) Add to Reading List Source URL: www.fda.gov Language: English Health Food and Drug Administration Food law Therapeutics Generic drug Pharmaceutical industry Federal Food Drug and Cosmetic Act Fee Prescription Drug User Fee Act Pharmaceutical sciences Pharmaceuticals policy Pharmacology
490	FY 2013 MDUFA Financial Report Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Clinical pharmacology Pharmacology Therapeutics United States Public Health Service Medical device Food and Drug Administration Amendments Act Prescription Drug User Fee Act Medicine Health Pharmaceutical sciences

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