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Improving Clinical Trial Patient’s ...

04/09/2024

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Informed Consent Forms (ICF) for clinical trials are required to communicate the essential details of a trial to prospective participants including the procedures, the risks of using the investigational product (IP) or device, and actions the participant would be expected to take during the trial (i.e., filling out questionaries, coming in for routine visits, etc.). As clinical trials continue to evolve and become increasingly complex, ICFs must accurately explain these complexities as they can lead to confusion for the intended audience.

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FDA Issues Updated Draft Guidance on Use of ...

04/02/2024

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The US Food and Drug Administration (FDA) published guidance on “Use of Data Monitoring Committees in Clinical Trials” in February 2024 which, once finalized, will take precedent over the FDA’s previous guide on the subject from 2006.  The guidance clarifies data monitoring committees’ (DMC) relevance and importance in clinical trial oversight, and how to determine when utilizing a DMC is practical for certain clinical trials.

Amanda Dzengeleski
FDA Issues Warning Letter for Clinical ...

01/03/2024

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On October 20, 2023, the FDA issued an investigator warning letter to Maria W. Greenwald, M.D.. The inspection was part of the FDA's Bioresearch Monitoring Program, aimed at assessing research conduct to safeguard the rights, safety, and well-being of human subjects. The investigation was conducted for several clinical studies, and there were multiple instances where the site failed to comply with investigational plans.

Amanda Dzengeleski
FDA Releases New Draft Guidance on Confirmatory ...

09/27/2023

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On September 18, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence to provide further detail on the accepted types of confirmatory evidence used to support the results of one adequate and well-controlled clinical investigation.

Jennifer Lawyer
FDA Releases 3 New Draft Guidances Regarding ...

09/13/2023

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On September 6, 2023 the US Food and Drug Administration (FDA) issued a bulletin announcing three new draft guidances regarding the FDA’s Center for Devices and Radiological Health’s (CDRH) 510(k) premarket submission program to verify that the medical device to be marketed is substantially equivalent to a legally marketed device as medical devices continue to become more complex and innovative.

Finalized FDA and OHRP Guidance on Electronic Informed Consent!

12/22/2016

The FDA and the OHRP announced the finalized version of the regulatory guidance document for electronic informed consent (eIC) “Use of Electronic Informed Consent—Questions and Answers” December 2016. The guidance document represents the current thinking of these regulatory agencies and are recommendations, but like this one, sometimes include requirements where applicable. It is of note that the FDA and OHRP combined their guidance together into one document to support ongoing efforts to harmonize between the agencies. This is great news for those that consent under FDA regulated trials and / or government sponsored research! This emphasizes the point that an eIC solution needs to be flexible to support very simple to complex projects, as well as from high-risk treatment to non-interventional studies.

“Monitoring Electronic Health Records (EHRs): FAQ and - Understanding the Recent May 2016 FDA Draft Guidance - Attend the UPCOMING WEB Session”

12/19/2016

Date: Dec 19, 2016

Time: 1pm - 2:30pm EST

Duration: 90 Minutes - Online

Sponsored by Life Science Training Institute

To Sign-up: http://www.lifesciencetraininginstitute.com/doc/monitoring-electronic-health-records-ehrs-0001

Description: 

In this session we will take an in depth look to the recent May 2016 FDA Draft Guidance as well as we will provide clear, practical answers to Frequently Asked Questions about Monitoring Electronic Health Records (EHR) including

21st Century Cures Act: Making Progress on Shared Goals for Patients

12/13/2016

THE US 21ST CENTURY CURES ACT WAS SIGNED INTO LEGISLATION YESTERDAY.  PLEASE SEE THE ANNOUNCEMENT BELOW. 

TODAY, PRESIDENT OBAMA SIGNED INTO LAW THE 21ST CENTURY CURES ACT, WHICH, I AM PLEASED TO REPORT, BUILDS ON FDA’S ONGOING EFFORTS TO ADVANCE MEDICAL PRODUCT INNOVATION AND ENSURE THAT PATIENTS GET ACCESS TO TREATMENTS AS QUICKLY AS POSSIBLE, WITH CONTINUED ASSURANCE FROM HIGH QUALITY EVIDENCE THAT THEY ARE SAFE AND EFFECTIVE.

Read more here http://blogs.fda.gov/fdavoice/index.php/2016/12/21st-century-cures-act-making-progress-on-shared-goals-for-patients/?source=govdelivery&utm_medium=email&utm_source=govdelivery