'Radiological health' presentation slideshows

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Interim Analysis in Clinical Trials: A Bayesian Approach in the Regulatory Setting

Interim Analysis in Clinical Trials: A Bayesian Approach in the Regulatory Setting

Interim Analysis in Clinical Trials: A Bayesian Approach in the Regulatory Setting Telba Z. Irony, Ph.D. and Gene Pennello, Ph.D . Division of Biostatistics Office of Surveillance and Biometrics Center for Devices and Radiological Health, FDA

By andrew
(398 views)

FDA/CDRH PUBLIC MEETING; Blood Glucose Meters

FDA/CDRH PUBLIC MEETING; Blood Glucose Meters

FDA/CDRH PUBLIC MEETING; Blood Glucose Meters. FDA Perspective: Regulatory Challenges for Safe use of Blood Glucose Meters in Hospital Settings Carol Benson, M.A., M.T.(ASCP) , Associate Director, Division of Chemistry and Toxicology Devices

By Thomas
(479 views)

What are the FDA Regulatory Requirements for Importing Medical Devices into the U.S.?

What are the FDA Regulatory Requirements for Importing Medical Devices into the U.S.?

What are the FDA Regulatory Requirements for Importing Medical Devices into the U.S.?. Carole C. Carey carole.carey@fda.hhs.gov Director, CDRH International Staff U.S. FDA Center for Devices and Radiological Health. Learning Objective.

By kimberly
(360 views)

DHHS/FDA/CDRH

DHHS/FDA/CDRH

DHHS/FDA/CDRH. FDA Summary. CYPHER ™ Sirolimus-Eluting Coronary Stent System Cordis Corporation PMA Application: P020026 October 22, 2002. DHHS/FDA/CDRH. Overview of Presentation. FDA Review Team Product Description Non-clinical Evaluation Clinical & Statistical Evaluation

By kiersten
(198 views)

FDA Office of Women’s Health Pregnancy Exposure Registry Website

FDA Office of Women’s Health Pregnancy Exposure Registry Website

Beverly Gallauresi RN, MPH Health Programs Coordinator AANP June 24, 2011. FDA Office of Women’s Health Pregnancy Exposure Registry Website. About FDA. The oldest consumer protection agency in the U.S. Ensures that regulated products are safe and effective. What FDA Regulates. Human Drugs.

By shani
(152 views)

Postmarket Surveillance of Medical Device Adverse Events

Postmarket Surveillance of Medical Device Adverse Events

Postmarket Surveillance of Medical Device Adverse Events. Hesha Jani Duggirala, PhD Epidemiology Branch Division of Postmarket Surveillance Office of Surveillance and Biometrics Center for Devices and Radiological Health. CDRH Background.

By bebe
(569 views)

Functional Vision Endpoints: OCTGT Perspective

Functional Vision Endpoints: OCTGT Perspective

Functional Vision Endpoints: OCTGT Perspective. Samuel B. Barone, M.D. Office of Cellular, Tissue, and Gene Therapies Center for Biologics Evaluation and Research samuel.barone@fda.hhs.gov NEI/FDA Endpoints Symposium May 6, 2011. Disclosure.

By abia
(139 views)

Humanitarian Device Exemptions (HDE) 101

Humanitarian Device Exemptions (HDE) 101

Humanitarian Device Exemptions (HDE) 101. Elizabeth Hillebrenner, MSE Biomedical Engineer IDE and HDE Program Staff Center for Devices and Radiological Health. Humanitarian Use Device.

By fola
(264 views)

CDRH: Minimizing Risk of TSE Agents in Medical Devices

CDRH: Minimizing Risk of TSE Agents in Medical Devices

CDRH: Minimizing Risk of TSE Agents in Medical Devices . CDR Martha O’Lone, RN, BSN CDRH TSE Working Group Chair Infection Control Devices Branch DAGID / ODE / FDA. Center for Devices and Radiological Health. * Ensure medical device safety and effectiveness

By mea
(132 views)

Wireless and Mobile Technologies for Healthcare: Ensuring Privacy, Security, and Availability

Wireless and Mobile Technologies for Healthcare: Ensuring Privacy, Security, and Availability

Wireless and Mobile Technologies for Healthcare: Ensuring Privacy, Security, and Availability. Thomas Jepsen Chair, IEEE-USA Medical Technology Policy Committee March 22, 2010. What is the MTPC?.

By truda
(140 views)

Medical Physicist Meeting Thursday, March 06, 2008 Agenda

Medical Physicist Meeting Thursday, March 06, 2008 Agenda

Medical Physicist Meeting Thursday, March 06, 2008 Agenda . Medical Physicist Meeting Thursday, March 06, 2008 Agenda . New BRH Staff. Paul Lee- Inspector BS Degree- Bio-medical Engineering, Rutgers University Mary Lazarides- Inspector BS Degree- Environmental Science, Ramapo College

By oya
(160 views)

TMI-2 Radiological Lessons Learned during Accident/Recovery Phases

TMI-2 Radiological Lessons Learned during Accident/Recovery Phases

TMI-2 Radiological Lessons Learned during Accident/Recovery Phases. David W. Miller, PhD, NATC Regional Director, ISOE Department of Nuclear, Plasma & Radiological Engineering College of Engineering, University of Illinois 2013 Asian ISOE ALARA Symposium Tokyo, Japan August 27-28, 2013.

By dinesh
(94 views)

Medical Physicist Meeting Thursday, March 06, 2008 Agenda

Medical Physicist Meeting Thursday, March 06, 2008 Agenda

Medical Physicist Meeting Thursday, March 06, 2008 Agenda . Medical Physicist Meeting Thursday, March 06, 2008 Agenda . New BRH Staff. Paul Lee- Inspector BS Degree- Bio-medical Engineering, Rutgers University Mary Lazarides- Inspector BS Degree- Environmental Science, Ramapo College

By brianne-haughey
(113 views)


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