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Biologic License Application
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41	AdvaMed Advanr rfd Medlt ;I/ Technology Assoclatioq October 18,2004 Add to Reading List Source URL: www.fda.gov Language: English - Date: 2004-11-05 15:30:47 Health Prescription Drug User Fee Act New Drug Application Center for Biologics Evaluation and Research Biologic License Application Biologic Food and Drug Administration Pharmaceutical sciences Medicine
42	OMB INFORMATION COLLECTION SUPPORTING STATEMENT New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy S Add to Reading List Source URL: www.fda.gov Language: English - Date: 2000-01-07 07:23:47 Pharmaceutical sciences Center for Biologics Evaluation and Research New Drug Application Regulatory requirement Biologic License Application Center for Drug Evaluation and Research Title 21 of the Code of Federal Regulations Biologic Prescription Drug User Fee Act Food and Drug Administration Medicine Health
43	Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act Add to Reading List Source URL: patentdocs.typepad.com Language: English - Date: 2014-08-14 01:02:03 Pharmacology Biosimilar Center for Biologics Evaluation and Research Biologic License Application New Drug Application Federal Food Drug and Cosmetic Act Investigational New Drug Food and Drug Administration Medicine Health
44	DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-12-08 14:30:51 Drug safety Safety Medical research Pharmacology Drotrecogin alfa Intensive care medicine New Drug Application Biologic License Application Eli Lilly and Company Food and Drug Administration Medicine Health
45	OMB INFORMATION COLLECTION SUPPORTING STATEMENT Add to Reading List Source URL: www.fda.gov Language: English - Date: 2005-10-06 10:05:35 Health Biologic License Application Center for Biologics Evaluation and Research Pharmaceutical industry Regulatory requirement Center for Drug Evaluation and Research Abbreviated New Drug Application Structured Product Labeling Prescription Drug User Fee Act Food and Drug Administration Pharmaceutical sciences Medicine
46	VIA HAND DELIVERY Division of Dockets Management U.S. Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD[removed]Re: Add to Reading List Source URL: www.fda.gov Language: English - Date: 2005-05-04 15:43:27 Pharmacology Biosimilar New Drug Application Biologic License Application Center for Biologics Evaluation and Research Generic drug Center for Drug Evaluation and Research Biologic Drug Price Competition and Patent Term Restoration Act Food and Drug Administration Medicine Pharmaceutical sciences
47	Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Biosimilar Center for Biologics Evaluation and Research Biologic License Application New Drug Application Federal Food Drug and Cosmetic Act Investigational New Drug Food and Drug Administration Medicine Health
48	Microsoft Word - 2920A0CD.doc Add to Reading List Source URL: www.fda.gov Language: English Clinical research Health Clinical pharmacology Therapeutics United States Public Health Service Center for Biologics Evaluation and Research Structured Product Labeling Biologic License Application Biologic Food and Drug Administration Medicine Pharmacology
49	SOPP 8406: Managing PDUFA User Fee Payments and Billing Activities Add to Reading List Source URL: www.fda.gov Language: English Health Pharmaceutical sciences Prescription Drug User Fee Act Federal Food Drug and Cosmetic Act Center for Biologics Evaluation and Research New Drug Application Patent application Biologic License Application FDA Special Protocol Assessment Food and Drug Administration Pharmaceuticals policy Medicine
50	Appendix 1 APLB - Advertising and Promotional Labeling Branch BiMo - Bioresearch Monitoring Branch, Division of Inspection and Surveillance, Office of Compliance and Biologics Quality BLA - biological license application Add to Reading List Source URL: www.fda.gov Language: English Health Biologic License Application New Drug Application Office of Regulatory Affairs Biologic Biostatistics Regulatory affairs Center for Biologics Evaluation and Research Food and Drug Administration Medicine Biotechnology

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