Tag Archives: FDA

ClinicalTrials.gov Pre-Notice & Notice of Noncompliance

The Food and Drug Administration (FDA) is taking action to ensure certain information in ClinicalTrials.gov is available to the public. On April 28, 2021, the FDA issued its first notice of non-compliance for failing to submit required results information. A Notice of Noncompliance indicates that the FDA has determined the Responsible Party (Principal Investigator) was […]

Posted in OCR | Also tagged , , , , | Comments closed

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 […]

Posted in IRB | Also tagged , , , | Comments closed

New Requirements for ClinicalTrials.gov

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

Posted in Announcements, Compliance, F&A, NIH, OCR, ORA Spotlight | Also tagged , , , , , , | Comments closed

New Requirements for Clinical Trials

March 29 Memo Regarding New Requirements for ClinicalTrials.gov

Posted in Announcements | Also tagged , , | Leave a comment

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 […]

Posted in EHSO | Also tagged , | Leave a comment

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 […]

Posted in OCR | Also tagged , | Comments closed

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 […]

Posted in Announcements, OCR | Also tagged , | Comments closed