Center for Biologics Evaluation and Research

Results: 1843



#Item
241Food and Drug Administration / Immunosuppressants / Amgen / Etanercept / Biologic / Rheumatoid arthritis / Center for Biologics Evaluation and Research / Biotechnology / Medicine / Pharmacology

. DEPARTMENT OF HEALTH 8a HUMAN SERVICES Food and Drug Administration 1401 Rockviile Pike

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Source URL: www.fda.gov

Language: English
242Clinical research / Center for Biologics Evaluation and Research / Food and Drug Administration / Influenza / Mahendra Rao / Maryland / Centers for Disease Control and Prevention / United States Public Health Service / Medicine / Health

1 U.S. FOOD AND DRUG ADMINISTRATION + + + + + CENTER FOR BIOLOGICS EVALUATION AND RESEARCH + + + + +

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Source URL: www.fda.gov

Language: English
243Clinical research / Health / Biologic / Center for Biologics Evaluation and Research / Genentech / Clinical trial / Food and Drug Administration / Pharmacology / Pharmaceutical sciences

Approval Letter - Alteplase (Cathflo), Genentech Incorporated[removed]

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Language: English
244Medicine / Pharmaceutical sciences / Biologic / Biosimilar / Center for Biologics Evaluation and Research / Full-time equivalent / Center for Drug Evaluation and Research / Pharmacology / Clinical research / Food and Drug Administration

FY 2013 BsUFA Financial Report

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Source URL: www.fda.gov

Language: English
245Food law / Pharmaceuticals policy / Unique Device Identification / Medical equipment / Medical device / Title 21 of the Code of Federal Regulations / Center for Biologics Evaluation and Research / Regulatory requirement / Federal Food /  Drug /  and Cosmetic Act / Food and Drug Administration / Medicine / Health

Attachment E CDRH Final Guidance Cover Sheet

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Source URL: www.fda.gov.

Language: English
246Biology / Pharmacology / Neurological disorders / Botulinum toxin / Plastic surgery / Center for Biologics Evaluation and Research / Spasmodic torticollis / Biologic / Title 21 of the Code of Federal Regulations / Medicine / Health / Food and Drug Administration

DEPARTMENT OF HEALTH & HUMAN

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247Biology / Clinical research / Pharmacology / Pharmaceutical industry / Design of experiments / Center for Biologics Evaluation and Research / Mucogingival junction / Clinical trial / Prescription Drug User Fee Act / Food and Drug Administration / Health / Medicine

CLINICAL REVIEW Division of Clinical Evaluation, Office of Cellular Tissue and Gene Therapy, Center for Biologics Evaluation and Research; with consultation from the Office of Device Evaluation, Division of Anesthesiolog

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248Stem cells / Technology / Packaging / ISBT 128 / Transfusion medicine / Pharmaceutical industry / Label / Cord blood bank / Cord blood / Biology / Medicine / Childbirth

MEMORANDUM Department of Health and Human Services Public Health Service Food and Drug Administration Center for Biologics Evaluation and Research

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249Clinical research / Food and Drug Administration / Blood banks / Center for Biologics Evaluation and Research / Influenza / Biologic / Validation / Whole blood / Pharmacology / Pharmaceutical sciences / Medicine

Public Workshop: Statistical Process Controls for Blood Establishments

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Source URL: www.fda.gov

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250Health / ISO standards / Pharmaceutical industry / Pharmaceuticals policy / Title 21 CFR Part 11 / United States administrative law / Portable Document Format / Center for Biologics Evaluation and Research / Arial / Food and Drug Administration / Medicine / Pharmaceutical sciences

Guidance for Industry Providing Regulatory Submissions in Electronic Format - General Considerations

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Source URL: www.fda.gov

Language: English
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