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Biologic license application
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61	New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2011 Add to Reading List Source URL: www.fda.gov Language: English Chemistry Research Organic chemistry Piperazines Pharmacology New Drug Application FDA Fast Track Development Program Aripiprazole Clinical trial Food and Drug Administration Clinical research Pharmaceutical industry
62	User Fees and Refunds for Premarket Approval Applications Add to Reading List Source URL: www.fda.gov Language: English Technology Premarket approval Federal Food Drug and Cosmetic Act Medical device Center for Devices and Radiological Health Title 21 of the Code of Federal Regulations Biologic License Application Center for Biologics Evaluation and Research Parts Manufacturer Approval Food and Drug Administration Medicine Health
63	New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplements (CY2010) Add to Reading List Source URL: www.fda.gov Language: English Amines Organochlorides Pharmaceutical industry Eli Lilly and Company Alcohols New Drug Application Darunavir Dasatinib Duloxetine Chemistry Organic chemistry Pharmacology
64	DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Silver Spring, MD[removed]August 2012 IMPORTANT INFORMATION ON THE MEDICAL DEVICE USER FEE R ATES FOR FY 2013: Add to Reading List Source URL: www.fda.gov Language: English Premarket approval Medical device Center for Devices and Radiological Health Fee Regulatory requirement Center for Biologics Evaluation and Research Biologic License Application Prescription Drug User Fee Act Food and Drug Administration Medicine Health
65	Federal Register / Vol. 77, No[removed]Wednesday, February 15, [removed]Notices manufactured, processed, packed, or held).1 All product applications should contain a complete and thorough Chemistry, Manufacturing, and Contro Add to Reading List Source URL: www.fda.gov Language: English Health Research Clinical research Pharmacology Pharmaceutical industry Biosimilar New Drug Application Biologic License Application Investigational New Drug Food and Drug Administration Medicine Drug safety
66	FOOD AND DRUG ADMINISTRATION Center for Biologics Evaluation and Research 106th Meeting of the Blood Products Advisory Committee FDA Fishers Lane Building 5630 Fishers Lane, Room 1066 Rockville, Maryland Add to Reading List Source URL: www.fda.gov Language: English Biology Botulinum toxin Botulism Center for Biologics Evaluation and Research Biologic License Application Project Bioshield Act Medicine Food and Drug Administration Health
67	As announced earlier this year, after a careful examination of Section 1847A of the Social Security Act, as established in the MMA of 2003, CMS has been working to ensure that accurate and separate payment is made for si Add to Reading List Source URL: cms.gov Language: English - Date: 2013-08-07 14:25:14 Clinical research Clinical pharmacology Therapeutics United States Public Health Service Biologic License Application Biologic New Drug Application MODDERN Cures Act Food and Drug Administration Pharmaceutical sciences Pharmacology
68	California Department of Public Health Laboratory Field Services State of California—Health and Human Services Agency BIOLOGICS LICENSE APPLICATION Add to Reading List Source URL: www.cdph.ca.gov Language: English - Date: 2014-06-23 14:52:04 Biologic License Application CHSC Address Law Humanities Food and Drug Administration ZIP code Maintenance fee
69	Application for Renewal of License for the Production of Biologics Add to Reading List Source URL: www.cdph.ca.gov Language: English - Date: 2014-06-23 14:52:05 Maintenance fee Food and Drug Administration Clinical research Law Pharmaceutical sciences Blood banks Pharmacology Biologic CHSC
70	Guidance for Industry and FDA Staffi Application User Fees for Combination Products DRAFT GU.IDAiVCE’-September This guidance document is being distributed Add to Reading List Source URL: www.fda.gov Language: English - Date: 2004-09-21 09:20:27 Health Prescription Drug User Fee Act Food and Drug Administration Modernization Act Federal Food Drug and Cosmetic Act New Drug Application Biologic License Application Medical device Premarket approval Center for Drug Evaluation and Research Food and Drug Administration Medicine Pharmaceutical sciences

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