FDA

The Feds Want (to hear from) YOU!

Uncle Sam pointingWhen we think of practicing citizenship, we often think about exercising the right to vote and calling our representatives. But did you know the federal government regularly seeks public comments about specific topics and rules that are under consideration?

 

Both NIH and FDA currently are currently seeking comments on topics of interest to the human subjects research community. Share your thoughts on informed consent language that fosters participant data and specimen sharing, leveraging existing data to advance pediatric drug development, and more.
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Education Round-up: July 2021

As a service to our research community, we periodically share upcoming non-Ohio State events, webinars, and workshops that may be of interest to human subjects researchers, research staff, and IRB members.

This month’s round-up includes a week-long FDA virtual conference on drugs, medical devices, and biologics regulations, as well as events on translation in clinical trials, bioethics, and a meeting of the DHHS Secretary’s Advisory Committee on Human Research Protections. All events are free or low-cost and open to the public but may require pre-registration.

This post was updated on July 15 to add and update the event list.

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Education Round-up: June 2021

As a service to our research community, we periodically share upcoming non-Ohio State events, webinars, and workshops that may be of interest to human subjects researchers, research staff, and IRB members.

This month’s round-up includes an OHRP Virtual Community Forum, as well as virtual events on recruitment using social media, improving inclusion of individuals with disabilities in research, IND safety reporting, and many others. All events are free or low-cost and open to the public but may require pre-registration.

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FDA-regulated Medical Device Research: Tools & webinar materials now available!

Image of the Berlin Heart medical device

Earlier this year, the Office of Responsible Research Practices held a two-part webinar series for researchers titled FDA-Regulated Research: Myth vs. Reality – Medical Devices. In this follow-up blog post, we cover where to find session materials and answer questions that we weren’t able to address during the session or that fell outside the scope of the learning objectives.

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What’s love got to do with it, FDA?

two hands holding heart-shaped lollipops on red backgroundThe ORRP education team is putting the final touches on our investigator tools and materials from our recent webinar on FDA-regulated device research. In the meantime, we invite you to check out this delightful Valentine’s Day-themed article recounting “all the ways in which the FDA has sent Warning Letters to companies for using the word love” from Alec Gaffney at POLITICO’s AgencyIQ. (Pro tip: Don’t list “love” as an ingredient in a food product!)

Read the full article, How the FDA regulates ‘love,’ at FDA Today and follow @AlecGaffney for the latest on FDA regulation of medical products.

Education Round-up: February 2021

As a service to our research community, we periodically share upcoming non-Ohio State events, webinars, and workshops that may be of interest to human subjects researchers, research staff, and IRB members. This month’s round-up includes virtual events on real world data/real world evidence, impacts of the new Administration on the life sciences, the ethics of artificial intelligence, and implications of deep phenotyping in psychiatry research. All events are free and open to the public but may require pre-registration.
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Webinar Follow-Up: FDA-Regulated Drug Research

On September 10, 2020, the Office of Responsible Research Practices held a webinar for researchers titled FDA-Regulated Research: Myth vs. Reality – Part 1: Drugs. In this follow-up blog post, we cover where to find session materials, introduce a “Test your knowledge” exercise, and answer questions that we weren’t able to address during the session or that fell outside the scope of the learning objectives.

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