Center for Drug Evaluation and Research

Results: 4314



#Item
611Technology / Medicine / Transfusion medicine / Cord blood bank / ISBT 128 / Packaging / Cord blood / Package insert / Label / Biology / Childbirth / Stem cells

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

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612Clinical research / Bioequivalence / Pharmacokinetics / Pharmaceuticals policy / Abbreviated New Drug Application / Generic drug / Center for Drug Evaluation and Research / Pharmaceutical sciences / Pharmacology / Food and Drug Administration

Disclaimer Statement The attached package contains background information prepared by the Food and Drug Administration (FDA) for the panel members of the advisory committee. The FDA background package might contain asses

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613Anatomy / Immunology / Food and Drug Administration / Center for Biologics Evaluation and Research / Influenza / Allergen / Standardization / Validation / Immunoglobulin E / Biology / Medicine / Immune system

DRAFT QUESTIONS February FOR APAC MEETING 10,200O

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Language: English - Date: 2000-02-09 02:50:20
614Health / Pharmaceutical sciences / Prescription Drug User Fee Act / Federal Food /  Drug /  and Cosmetic Act / Mammography Quality Standards Act / Abbreviated New Drug Application / Generic drug / Center for Drug Evaluation and Research / Prescription medication / Food and Drug Administration / Pharmaceuticals policy / Medicine

Current Law User Fees +$74,359,000 1. Why are these amounts necessary? FDA user fee programs facilitate enhanced premarket review performance and the timely

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615Food and Drug Administration / Clinical research / Pharmaceutical industry / Validation / Cord blood / Gene therapy / Center for Biologics Evaluation and Research / Current Good Tissue Practices / Biology / Biotechnology / Stem cells

Update on OCTGT Guidance Development Program

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Language: English - Date: 2008-03-27 11:33:16
616Pharmacology / Center for Drug Evaluation and Research / Food and Drug Administration / Pharmaceutical sciences / Clinical research

FOOD AND DRUG ADMINISTRATION (FDA) CENTER FOR DRUG EVALUATION AND RESEARCH (CDER) Gastrointestinal Drugs Advisory Committee (GIDAC) FDA White Oak Campus, Building 31, the Great Room, White Oak Conference Center (Rm. 1503

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617Pharmaceutical sciences / Federal Food /  Drug /  and Cosmetic Act / Center for Biologics Evaluation and Research / Debarment / New Drug Application / Food and Drug Administration / Medicine / Health

[removed]Federal Register / Vol. 61, No[removed]Friday, March 22, [removed]Notices Board of Governors of the Federal Reserve System, March 18, 1996.

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618Pharmacology / Clinical research / Pharmaceutical industry / Drug discovery / Center for Drug Evaluation and Research / FDA Fast Track Development Program / Drug development / Clinical trial / Chronic fatigue syndrome / Health / Food and Drug Administration / Pharmaceutical sciences

Microsoft Word - Background Information.doc

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619Food and Drug Administration / Pharmacology / Epoxides / Thiophenes / Tiotropium bromide / Boehringer Ingelheim / Respimat / Chronic obstructive pulmonary disease / Center for Drug Evaluation and Research / Medicine / Health / Bronchodilators

FOOD AND DRUG ADMINISTRATION (FDA)

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620Chemistry / Mood stabilizers / Epilepsy / Lamotrigine / Organochlorides / Triazines / Phenytoin / Food and Drug Administration / Retigabine / Anticonvulsants / Medicine / Pharmacology

Food and Drug Administration Center for Drug Evaluation and Research Summary Minutes of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting March 10, 2011

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