Tag Archives: FDA

The Revised Common Rule is Almost Here!

Effective January 21, 2019, human subjects research is subject to revised regulations. *Please note that FDA has not yet harmonized, so parts of the new Rule cannot be applied to FDA-regulated research.* Details are available in our recent webinars here: http://irb.emory.edu/Training/webinars.html. What will you see in eIRB? If you submit, or edit a new submission, after […]

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New Requirements for ClinicalTrials.gov

  Click here to learn about the new requirements for ClinicalTrials.gov.  

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New Requirements for Clinical Trials

March 29 Memo Regarding New Requirements for ClinicalTrials.gov

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FDA Ban on Powdered Medical Gloves

What? Powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove have been banned by the FDA (Food and Drug Administration). Why? These “medical devices” pose a significant risk to healthcare workers and patients. What is the scope of the rule? The ban applies to devices manufactured, in storage, or […]

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New ClinicalTrials.gov FDA regulation and NIH policy

Written by: Jennifer Prozonic Office for Clinical Research  Changes and Impact of FDA Final Rule & NIH Policy for ClinicalTrials.gov In September of 2016, the U.S. Department of Health and Human Services issued a final rule expanding the scope of ClinicalTrials.gov and requiring additional registration and results reporting requirements to the existing Food and Drug […]

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Should Your Research Be Registered on ClinicalTrials.Gov?

If a research study meets any one of the following definitions, the trial must be registered on ClinicalTrials.gov: The Food and Drug Administration (FDA) requires registration for “applicable clinical trials” (ACTs) defined as follows: For any trials of drugs and biologics:  controlled clinical investigations, other than Phase I investigations, of a product subject to FDA […]

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