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Biologic License Application
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71	[removed]Federal Register / Vol. 77, No[removed]Friday, May 18, [removed]Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2014-05-29 17:04:43 Health Prescription Drug User Fee Act New Drug Application Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Pharmaceutical industry Federal Food Drug and Cosmetic Act Biologic License Application Food and Drug Administration Pharmaceutical sciences Medicine
72	42 USCA § [removed]U.S.C.A. § 262 Page 2 UNITED STATES CODE ANNOTATED Add to Reading List Source URL: www.selectagents.gov Language: English - Date: 2009-08-10 07:59:55 Technology Business Ethology Food and Drug Administration Biologic License Application Packaging and labeling
73	PDF Document Add to Reading List Source URL: www.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
74	PDF Document Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Prescription Drug User Fee Act Federal Food Drug and Cosmetic Act Abbreviated New Drug Application Center for Biologics Evaluation and Research New Drug Application Biologic License Application Center for Drug Evaluation and Research Food and Drug Administration Medicine Health
75	PDF Document Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Center for Drug Evaluation and Research New Drug Application Investigational New Drug Premarket approval Biologic License Application Regulatory requirement Biologic Prescription Drug User Fee Act Food and Drug Administration Medicine Health
76	This document is scheduled to be published in the Federal Register on[removed]and available online at http://federalregister.gov/a[removed], and on FDsys.gov[removed]P DEPARTMENT OF HEALTH AND HUMAN SERVICES Add to Reading List Source URL: s3.amazonaws.com Language: English - Date: 2013-10-31 11:13:45 Health Pharmacology Pharmaceuticals policy Food law Therapeutics Federal Food Drug and Cosmetic Act New Drug Application Center for Biologics Evaluation and Research Biologic License Application Food and Drug Administration Medicine Pharmaceutical sciences
77	CDER Therapeutic Biologic Billable List Mmm yy Add to Reading List Source URL: www.fda.gov Language: English Ustekinumab Biologic License Application Food and Drug Administration BLA
78	Microsoft PowerPoint - Courtney.PublicHealthLawConf[removed]no photos.pptx Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences New Drug Application Federal Food Drug and Cosmetic Act Daily Med Medical device Biologic License Application Premarket approval Criticism of the Food and Drug Administration Center for Devices and Radiological Health Food and Drug Administration Medicine Health
79	8883 Federal Register / Vol. 77, No[removed]Wednesday, February 15, [removed]Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 351(k) Application for biosimilars (42 U.S.C. 262(k[removed]l)(6)(C) ............. Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2013-05-23 13:09:03 Health Biosimilar New Drug Application Biologic License Application Center for Biologics Evaluation and Research Biologic Investigational New Drug Food and Drug Administration Medicine Pharmaceutical sciences
80	Microsoft Word - Final User Fee Guidance Cleared by OCC _3-31-05_.doc Add to Reading List Source URL: www.fda.gov Language: English Health Prescription Drug User Fee Act Food and Drug Administration Modernization Act Federal Food Drug and Cosmetic Act New Drug Application Premarket approval Medical device Biologic License Application Center for Devices and Radiological Health Food and Drug Administration Medicine Pharmaceutical sciences

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