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Humanitarian Device Exemption
Results: 101

#	Item
31	The Honorable Rosa DeLauro 2413 Rayburn House Office Building Washington, DC[removed]February 6, 2014 Dear Congresswoman DeLauro, Add to Reading List Source URL: npalliance.org Language: English - Date: 2014-02-06 13:40:45 Health Clinical research Clinical trial New Drug Application Humanitarian Device Exemption Pharmacology Food and Drug Administration Pharmaceutical sciences
32	Institutional Review Boards and Humanitarian Use Device (HUD) Presented by Fabienne Santel, MD Division of Bioresearch Monitoring Office of Compliance Add to Reading List Source URL: www.fda.gov. Language: English Health Pharmaceutical sciences Clinical research Humanitarian Device Exemption Food law Premarket approval Institutional review board Title 21 of the Code of Federal Regulations Center for Devices and Radiological Health Food and Drug Administration Medicine Pharmacology
33	Food and Drug Administration Center for Biologics Evaluation and Research Advisory Committee on Cellular, Tissue and Gene Therapies Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Humanitarian Device Exemption Federal Food Drug and Cosmetic Act Premarket approval Medical device Clinical trial Food and Drug Administration Medicine Health
34	Humanitarian Use Devices Theodore Stevens, MS, RAC Office of Cellular, Tissue and Gene Therapies Center for Biologics Evaluation and Research Add to Reading List Source URL: www.fda.gov Language: English Technology Humanitarian Device Exemption Premarket approval Medical device Federal Food Drug and Cosmetic Act Food and Drug Administration Medicine Health
35	Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and Food and Drug Administration Staff Humanitarian Device Exemption (HDE) Regulation: Questions and Answers Add to Reading List Source URL: www.fda.gov Language: English Technology Humanitarian Device Exemption Medical device Investigational Device Exemption Federal Food Drug and Cosmetic Act Premarket approval Title 21 of the Code of Federal Regulations Center for Biologics Evaluation and Research Medicine Food and Drug Administration Health
36	Protocols, IRB#S, Sponsors, HDE#, IDE# Humanitarian device Exemption (HDE)#H000001 JOMED Coronary Stent Graft IRB#2K1-10 Add to Reading List Source URL: www.deborah.org Language: English - Date: 2013-07-02 07:35:10 Cardiology Medical equipment Pharmaceutical industry Drug-eluting stent Coronary stent Clinical trial Stent Ventricular assist device Restenosis Medicine Interventional cardiology Implants
37	Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff Add to Reading List Source URL: www.fda.gov. Language: English Technology Food law Pharmaceuticals policy Clinical research Pharmacology Humanitarian Device Exemption Premarket approval Federal Food Drug and Cosmetic Act Medical device Food and Drug Administration Medicine Health
38	How Can an International TAVR Consortium Benefit FDA Premarket Evaluation of TAVR Devices: An FDA PreMarket Perspective Bram Zuckerman, MD, FACC Add to Reading List Source URL: www.fda.gov Language: English Clinical research Research Pharmacology Design of experiments Epidemiology Premarket approval Medical device Humanitarian Device Exemption Center for Devices and Radiological Health Food and Drug Administration Medicine Health
39	Overview of CDRH Premarket and Postmarket Process LCDR Mary E. Brooks RN,BSN,MS Product Evaluation Branch II 1 Add to Reading List Source URL: www.fda.gov Language: English Technology Premarket approval Medical device Center for Devices and Radiological Health Humanitarian Device Exemption Investigational Device Exemption Federal Food Drug and Cosmetic Act Food and Drug Administration Medicine Health
40	DEPARTMENT OF HEALTH &HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Avenue Silver Spring, MD 20993 Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2013-12-05 18:34:05 Pharmaceutical sciences Pharmacology Clinical research Pharmaceutical industry Medical technology Medical device Federal Food Drug and Cosmetic Act Humanitarian Device Exemption Adverse effect Medicine Health Food and Drug Administration

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