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Biologic
Results: 1831

#	Item
771	healthcare provider letter Add to Reading List Source URL: www.fda.gov Language: English Immunosuppressants Monoclonal antibodies Autoimmune diseases Centocor Infliximab Schering-Plough Rheumatoid arthritis Biologic Arthritis Medicine Health Pharmacology
772	CDER Drug and Biologic Calendar Year Priority Approvalsin Calendar Year 2010 Add to Reading List Source URL: www.fda.gov Language: English Cyclopropanes Lactams Nevirapine Pyridines Eribulin Lamivudine Fingolimod Oxycodone Chemistry Organic chemistry Immunosuppressants
773	Food and Drug Administration Add to Reading List Source URL: www.fda.gov Language: English Clinical research Food and Drug Administration Center for Biologics Evaluation and Research Influenza Biologic Retrovirus Virus Biologics Control Act Biotechnology Pharmacology Medicine
774	CDER Drug and Biologic Approvals for Calendar Year 2013 Add to Reading List Source URL: www.fda.gov Language: English New Drug Application Pharmaceutical industry Gilead Sciences Tenofovir Pharmaceutical industry in Bangladesh Hospira Pharmacology Pharmaceutics Pharmaceutical sciences Clinical research Drug safety Food and Drug Administration
775	December 15, 2009: Vaccines & Related Biological Products Advisory Committee Meeting Agenda Add to Reading List Source URL: www.fda.gov Language: English Clinical research Food and Drug Administration Center for Biologics Evaluation and Research Influenza Biologic Retrovirus Virus Biologics Control Act Biotechnology Pharmacology Medicine
776	PDF Document Add to Reading List Source URL: www.fda.gov Language: English Immunosuppressants Clinical research Amgen Etanercept Rheumatoid arthritis Tumor necrosis factor-alpha Biologic Placebo Clinical trial Medicine Health Pharmacology
777	Guidance for Industry Accelerated Approval Products — Submission of Promotional Materials DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Biologic FDA Fast Track Development Program Federal Food Drug and Cosmetic Act Prescription Drug User Fee Act Structured Product Labeling Food and Drug Administration Medicine Health
778	Staff Manual Guide[removed] Add to Reading List Source URL: www.fda.gov Language: English Center for Devices and Radiological Health Center for Biologics Evaluation and Research Medical device Premarket approval Center for Drug Evaluation and Research Federal Food Drug and Cosmetic Act Biologic Food and Drug Administration Medicine Health
779	SMG 4101 FDA STAFF MANUAL GUIDES, VOLUME IV - AGENCY PROGRAM DIRECTIVES COMBINATION PRODUCTS INTERCENTER CONSULTATIVE/COLLABORATIVE REVIEW PROCESS Effective Date: June 18, 2004 Add to Reading List Source URL: www.fda.gov Language: English Clinical research Biologic Center for Devices and Radiological Health Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Investigational New Drug Food and Drug Administration Medicine Health
780	Staff Manual Guide[removed] Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Health Drug safety Center for Drug Evaluation and Research United States Department of Health and Human Services Center for Biologics Evaluation and Research Investigational New Drug Biologic New Drug Application Food and Drug Administration Pharmacology Medicine

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