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Biologic license application
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11	DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD[removed]MEMORANDUM Date: Add to Reading List Source URL: www.fda.gov Language: English Chemistry Science Pharmaceutical industry Clinical research Validity Center for Biologics Evaluation and Research Biologic License Application Validation Biologic Food and Drug Administration Pharmaceutical sciences Pharmacology
12	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: 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
13	CDER List of Licensed Biological Products with (1) Reference Product Exclusivity and (2) Biosimilarity or Interchangeability Evaluations to Date Add to Reading List Source URL: www.fda.gov Language: English Cytokines Biology Biosimilar Interferon Peginterferon alfa-2a Ribavirin Biologic License Application Biologic Peginterferon alfa-2b Antivirals Pharmacology Medicine
14	Implementatino of Biologics License; Elimination of Establishment License and Product License Public Workshop Add to Reading List Source URL: www.fda.gov Language: English Health Pharmaceutical sciences Pharmaceuticals policy Therapeutics United States Public Health Service Center for Biologics Evaluation and Research Biologic License Application Biologic Food and Drug Administration Medicine Pharmacology
15	sgg AT DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH Add to Reading List Source URL: www.fda.gov Language: English Medicine Pharmaceutical sciences Center for Biologics Evaluation and Research Influenza Biologic License Application Biologic BLA Food and Drug Administration Pharmacology Clinical research
16	[removed]Federal Register / Vol. 73, No[removed]Monday, November 24, [removed]Notices Section 903(b)(2)(c) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 393(b)(2)(c)) authorizes FDA to Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences New Drug Application Debarment Center for Biologics Evaluation and Research Federal Food Drug and Cosmetic Act Biologic License Application Investigational New Drug Prescription Drug User Fee Act Criticism of the Food and Drug Administration Food and Drug Administration Medicine Health
17	DEPARTMENT OF HEALTH & HUMAN Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Clinical research Pharmaceutical industry Medical informatics Biologic License Application Biologic Package insert Center for Biologics Evaluation and Research Food and Drug Administration Medicine Pharmacology
18	DEPARTMENT OF HEALTH & HUMAN Add to Reading List Source URL: www.fda.gov Language: English Health Biotechnology Biologic License Application Center for Biologics Evaluation and Research Biologic Genentech Adverse effect Pharmacology Medicine Food and Drug Administration
19	PDF Document Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Biology Epoetin alfa Erythropoietin Amgen Biologic License Application Food and Drug Administration Biologic Medicine Erythropoiesis-stimulating agents Growth factors
20	T810.01 Regulatory SOPP Template Add to Reading List Source URL: www.fda.gov Language: English Medicine Pharmaceutical sciences Center for Biologics Evaluation and Research Influenza Biologic License Application Biologic Food and Drug Administration Pharmacology Clinical research