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Investigational Device Exemption
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#	Item
21	SOP 24. OHSRP REPORTING TO THE OFFICE FOR HUMAN RESEARCH Add to Reading List Source URL: ohsr.od.nih.gov Language: English - Date: 2014-03-10 08:07:02 Health Office for Human Research Protections Food and Drug Administration National Institutes of Health Investigational Device Exemption Investigational New Drug Human subject research Institutional review board Clinical research coordinator Clinical research Research Medicine
22	Federal Register / Vol. 80, NoMonday, May 18, Notices written comments to the Division of Dockets Management (HFA–305), Food Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2015-05-16 00:52:45 Technology Clinical research Pharmaceutical industry Drug safety Medical device Medical equipment Investigational New Drug Investigational Device Exemption Premarket approval Food and Drug Administration Medicine Health
23	IDE Basics November 4, 2014 Soma Kalb Director (Acting) Investigational Device Exemption (IDE) Program Office of Device Evaluation Add to Reading List Source URL: www.fda.gov Language: English Health Research Pharmacology Pharmaceutical industry Food law Investigational Device Exemption IDE Institutional review board Federal Food Drug and Cosmetic Act Food and Drug Administration Medicine Clinical research
24	Microsoft Word - MCM_HRPP_docx Add to Reading List Source URL: www.research.ucsf.edu Language: English - Date: 2013-03-22 21:43:48 Pharmaceutical industry Medicine Pharmacology Drug safety Food and Drug Administration Institutional review board Clinical trial Investigational Device Exemption Investigational New Drug Clinical research Research Health
25	Reference Table of Award Mechanisms Add to Reading List Source URL: cdmrp.army.mil Language: English - Date: 2015-05-28 09:18:54 Pharmaceutical industry Food and Drug Administration Health Cancer organizations Nursing research Clinical trial Investigational New Drug Funding Opportunity Announcement Investigational Device Exemption Medicine Clinical research Research
26	Administrative Manual Policy Name Policy Number Date this Version Effective Responsible for Content Add to Reading List Source URL: research.unc.edu Language: English - Date: 2012-11-27 10:40:01 Health Pharmacology Pharmaceutical industry Food and Drug Administration Drug safety Investigational Device Exemption Expanded access Investigational New Drug Clinical trial Clinical research Research Medicine
27	STANDARD CLINICAL TRIAL AGREEMENT __________ (“Sponsor”), a {form of entity} organized under the laws of {State} and the Board of Regents of the University of Wisconsin System (“Site”), a state-controlled higher Add to Reading List Source URL: www.rsp.wisc.edu Language: English - Date: 2015-01-06 13:40:21 Science Design of experiments Pharmacology Scientific method Clinical trial Institutional review board Case report form Investigational Device Exemption Trade secret Clinical research Research Pharmaceutical industry
28	Joan and Sanford I. Weill Medical College of Cornell University Institutional Review Board Policies and Procedures for Research Add to Reading List Source URL: researchintegrity.weill.cornell.edu Language: English - Date: 2014-01-31 10:15:41 Health Pharmacology Medical ethics Drug safety Medical research Institutional review board Declaration of Helsinki Investigational New Drug Investigational Device Exemption Research Clinical research Medicine
29	Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure1 Applicability (A) Research activities that (1) present no more than minimal risk to human subject Add to Reading List Source URL: www.rpi.edu Language: English - Date: 2011-08-29 10:50:54 Science Pharmaceutical industry Drug safety Food and Drug Administration Pharmacology Institutional review board Investigational Device Exemption Investigational New Drug Clinical trial Clinical research Research Medicine
30	21 CFRb)(1) To be exempt under this category, all of these sub-requirements must apply: The clinical investigation involves a drug product lawfully marketed in the U.S. Yes The investigation is not intended to be Add to Reading List Source URL: research.unc.edu Language: English - Date: 2013-04-10 14:57:04 Pharmacology Pharmaceuticals policy Drug safety Food and Drug Administration Food law Prescription medication Title 21 of the Code of Federal Regulations Investigational New Drug Investigational Device Exemption Medicine Health Pharmaceutical sciences

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