Investigational Device Exemptions Manual
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Author |
: |
Publisher |
: |
Total Pages |
: 124 |
Release |
: 1992 |
ISBN-10 |
: MINN:20000004227860 |
ISBN-13 |
: |
Rating |
: 4/5 (60 Downloads) |
Synopsis Investigational Device Exemptions Manual by :
Author |
: Center for Devices and Radiological Health (U.S.). Division of Small Manufacturers Assistance |
Publisher |
: |
Total Pages |
: 220 |
Release |
: 1996 |
ISBN-10 |
: IND:30000105703528 |
ISBN-13 |
: |
Rating |
: 4/5 (28 Downloads) |
Synopsis Investigational Device Exemptions Manual by : Center for Devices and Radiological Health (U.S.). Division of Small Manufacturers Assistance
Author |
: |
Publisher |
: |
Total Pages |
: 147 |
Release |
: 1990 |
ISBN-10 |
: OCLC:22723139 |
ISBN-13 |
: |
Rating |
: 4/5 (39 Downloads) |
Synopsis Investigational Device Exemptions Manual by :
Author |
: Center for Devices and Radiological Health (U.S.). Division of Small Manufacturers Assistance |
Publisher |
: |
Total Pages |
: 220 |
Release |
: 1996 |
ISBN-10 |
: UOM:39015038600071 |
ISBN-13 |
: |
Rating |
: 4/5 (71 Downloads) |
Synopsis Investigational Device Exemptions Manual by : Center for Devices and Radiological Health (U.S.). Division of Small Manufacturers Assistance
Author |
: |
Publisher |
: |
Total Pages |
: 220 |
Release |
: 1996 |
ISBN-10 |
: MINN:30000005032085 |
ISBN-13 |
: |
Rating |
: 4/5 (85 Downloads) |
Synopsis Investigational Device Exemptions Manual by :
Author |
: |
Publisher |
: |
Total Pages |
: 440 |
Release |
: 1983 |
ISBN-10 |
: MINN:20000004227878 |
ISBN-13 |
: |
Rating |
: 4/5 (78 Downloads) |
Synopsis Regulatory Requirements for Medical Devices by :
Author |
: United States. Food and Drug Administration |
Publisher |
: |
Total Pages |
: 24 |
Release |
: 1992-11 |
ISBN-10 |
: MINN:31951D03729034G |
ISBN-13 |
: |
Rating |
: 4/5 (4G Downloads) |
Synopsis Staff Manual Guide Transmittal No. ... by : United States. Food and Drug Administration
Author |
: United States. Food and Drug Administration |
Publisher |
: |
Total Pages |
: 34 |
Release |
: 1998-10 |
ISBN-10 |
: MINN:31951D03732719D |
ISBN-13 |
: |
Rating |
: 4/5 (9D Downloads) |
Synopsis FDA Compliance Program Guidance Manual by : United States. Food and Drug Administration
Author |
: Center for Devices and Radiological Health (U.S.). Office of Device Evaluation |
Publisher |
: |
Total Pages |
: 144 |
Release |
: 1986 |
ISBN-10 |
: SRLF:EE0000206813 |
ISBN-13 |
: |
Rating |
: 4/5 (13 Downloads) |
Synopsis Premarket Approval (PMA) Manual by : Center for Devices and Radiological Health (U.S.). Office of Device Evaluation
Author |
: Cynthia McGuire Dunn |
Publisher |
: |
Total Pages |
: 392 |
Release |
: 2004 |
ISBN-10 |
: UOM:39015061377969 |
ISBN-13 |
: |
Rating |
: 4/5 (69 Downloads) |
Synopsis Protecting Study Volunteers in Research by : Cynthia McGuire Dunn
Protecting Study Volunteers in Research is a suggested educational resource by NIH and FDA (source: NIH Notice OD-00-039, 2000, page 37841, Federal Registry 2002) and has become required reading in many academic institutions, IRBs, investigative sites, and for many Biopharmaceutical and CRO companies. This well-organized and concise manual teaches organizations how to successfully implement the highest standards of safe and ethical treatment of study volunteers while addressing current and emerging issues that are critical to our system of human subject protection oversight. Topics covered include: Conflicts of interest in research, Participant recruitment and retention in clinical trials, Research with secondary subjects, tissue studies, and records review, Historical perspectives on human subject research, Updated ethics and federal regulations, Roles and responsibilities of institutions and independent sites, Roles and responsibilities of investigators and the study process. --Amazon.com