Rems

Results: 587



#Item
491Health / Pharmaceutical industry / Drugs / Pharmaceuticals policy / Food and Drug Administration / Therapeutics / Package insert / Prescription medication / Pharmaceutical sciences / Medicine / Pharmacology

FDA Basics Webinar: REMS Overview

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Source URL: www.fda.gov

Language: English
492Disaster preparedness / Humanitarian aid / Occupational safety and health / United States Department of Homeland Security / Public Safety Canada / National Incident Management System / United States Department of Education / Federal Emergency Management Agency / Public safety / Emergency management / Safety

Practical Information on Crisis Planning: A Guide for Schools and Communities -- April[removed]PDF)

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Source URL: rems.ed.gov

Language: English - Date: 2010-08-18 19:31:05
493Pharmacology / Clinical pharmacology / Therapeutics / United States Public Health Service / Prescription Drug User Fee Act / Pharmaceutical sciences / Food and Drug Administration / Clinical research

Page 1 FOOD AND DRUG ADMINISTRATION + + + + + STANDARDIZING AND EVALUATING RISK EVALUATION AND MITIGATION STRATEGIES (REMS) + + + + +

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Source URL: www.fda.gov

Language: English
494Food and Drug Administration / Clinical pharmacology / Pharmacology / Therapeutics / United States Public Health Service / Prescription Drug User Fee Act / Rems / Roentgen equivalent man / Medicine / Health / Pharmaceutical sciences

FDA Public Meeting Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS) July 25, 2013

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Source URL: www.fda.gov

Language: English
495Ketones / Drug rehabilitation / Eli Lilly and Company / Piperazines / Methadone / Cinoxacin / Norfloxacin / Chemistry / Organic chemistry / Amines

APPENDIX A – REMS Initial REMS Approval: [removed]Most Recent Modification: XX/2011 NDA[removed]POTIGA™ (ezogabine) Tablets Drug Class: Anticonvulsant

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Source URL: www.fda.gov

Language: English
496Peptide hormones / Thyroid cancer / Anti-diabetic drugs / Diabetes / Liraglutide / Medullary thyroid cancer / Thyroid neoplasm / Multiple endocrine neoplasia type 2 / Novo Nordisk / Medicine / Anatomy / Endocrine system

APPENDIX A: REMS Initial REMS approval: [removed]Most recent modification: [removed]NDA[removed]VICTOZA® (liraglutide [rDNA origin] injection) Novo Nordisk Inc.

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Source URL: www.fda.gov

Language: English
497Apixaban / Bristol-Myers Squibb / Lactams / Piperidines / Cardiac dysrhythmia / Atrial fibrillation / Warfarin / Stroke / Thrombosis / Chemistry / Organic chemistry / Anticoagulants

Initial REMS Approval Date: [removed]NDA[removed]ELIQUIS® (apixaban) tablets Factor Xa Inhibitor Bristol-Myers Squibb Company

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Source URL: www.fda.gov

Language: English
498Eli Lilly and Company / Teriparatide / Osteopathies / Osteoporosis / Osteosarcoma / Bone fracture / Bone density / Medical prescription / Medicine / Health / Drugs

Page 1 Initial REMS Approval: July 2009 Most Recent Modification: August 2013 NDA[removed]FORTEO® (teriparatide) (rDNA origin) Injection

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Source URL: www.fda.gov

Language: English
499Dronedarone / Sulfonamides / Sanofi / Chemistry / Organic chemistry / Benzofurans

Initial REMS Approval: July 2009 Most Recent Modification: March 2014 NDA[removed]Multaq® (dronedarone) sanofi-aventis U.S. 55 Corporate Boulevard Bridgewater, New Jersey 08807

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Source URL: www.fda.gov

Language: English
500Drug rehabilitation / Dosage forms / Substance dependence / Morphinans / Buprenorphine / Opioid dependence / Drug Addiction Treatment Act / Methadone / Reckitt Benckiser / Chemistry / Pharmacology / Medicine

Initial REMS Approval: December[removed]NDA[removed]SUBUTEX® (buprenorphine) sublingual tablet CIII Buprenorphine (opioid partial agonist-antagonist)

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Source URL: www.fda.gov

Language: English
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