May 19, 2014 9:00 AMHS ERA News

Beginning February 17, 2014, the IRB is launching a new pilot initiative to facilitate the process of determining which projects are QI/QA and which projects are considered research

Apr 15, 2014 9:00 AMHumanitarian Device Exemption Guidance

The FDA recently issued the following guidance for Humanitarian Device Exemption (HDE): Questions and Answers, Draft Guidance for HDE Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff

Apr 15, 2014 9:00 AMClinical Trials.gov

Guidance for posting your trial on Clinical Trials.gov:

http://clinicaltrials.gov/ct2/info/fdalinks

Apr 15, 2014 9:00 AMIRB releases new IRB Standard Operating Policies and Guide to Daily Operations

Apr 15, 2014 8:00 AMQuality Assurance (QA)/Quality Improvement (QI) Research Pilot Project

Distinguishing between quality improvement (QI)/quality assurance initiatives (QA) and human subjects’ research requiring IRB review is often challenging, especially when there is an overlap between these goals.Beginning February 17, 2014, the IRB is launching a new pilot initiative t

Apr 15, 2014 7:00 AMFDA News: HUD Guidance

Guidance for Industry and FDA Staff - Humanitarian Use Device (HUD) Designations 

Apr 01, 2014 9:00 AMFDA News

Device Advice:

Mar 01, 2014 9:30 PMhold for news

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Mar 01, 2014 8:00 PMhold for news

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Mar 01, 2014 9:00 AMhold for news


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Mar 01, 2014 6:45 AMhold for news

hold for news