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FDA Looks to Optimize the Processes and ...

05/14/2024

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On April 29th, 2024 the US Food and Drug administration (FDA) posted a news release outlining an upcoming virtual listening session June 13th, 2024 from 9:00am–4:00pm ET, on the optimal use of and processes for FDA advisory committees (Ad Com). FDA Ad Coms are intended to provide the agency with advice and recommendations from the public as well as external experts from various backgrounds. They review the safety, effectiveness, and appropriate use of products in FDA regulated research by discussing scientific, technical, and policy issues and voting on proposed future actions.

FDA Looks to Optimize the Processes and Policies of Advisory Committees
Guest User
CDER Unveils Center for Clinical Trial ...

04/30/2024

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On April 15th, 2024 the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) announced the establishment of the CDER Center for Clinical Trial Innovation (C3TI). Clinical trial design and conduct must be held to rigorous standards and policies in order to safeguard the well-being of trial participants and the public. These standards and policies are outlined within the ICH E8(R1) Guideline: General Considerations for Clinical Studies.

Guest User
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FDA Issues Updated Draft Guidance on Use of ...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.

FDA Looks to Optimize the Processes and Policies of Advisory Committees

FDA Looks to Optimize the Processes and Policies of Advisory Committees

05/14/2024

-

On April 29th, 2024 the US Food and Drug administration (FDA) posted a news release outlining an upcoming virtual listening session June 13th, 2024 from 9:00am–4:00pm ET, on the optimal use of and processes for FDA advisory committees (Ad Com). FDA Ad Coms are intended to provide the agency with advice and recommendations from the public as well as external experts from various backgrounds. They review the safety, effectiveness, and appropriate use of products in FDA regulated research by discussing scientific, technical, and policy issues and voting on proposed future actions.

CDER Unveils Center for Clinical Trial Innovation (C3TI)

04/30/2024

-

On April 15th, 2024 the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) announced the establishment of the CDER Center for Clinical Trial Innovation (C3TI). Clinical trial design and conduct must be held to rigorous standards and policies in order to safeguard the well-being of trial participants and the public. These standards and policies are outlined within the ICH E8(R1) Guideline: General Considerations for Clinical Studies.

FDA Issues Warning Letter to IRB Following BIMO Inspection

04/23/2024

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On March 21, 2024 the Centre for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) issued a warning letter to the New York State Psychiatric Institute (NYSPI) institutional review board (IRB). The FDA’s inspection resulted in six major observations, all of which occurred during convened IRB meetings.

Improving Clinical Trial Patient’s Comprehension of Informed Consent Forms

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.

FDA Issues Updated Draft Guidance on Use of Data Monitoring Committees in Clinical Trials

04/02/2024

-

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.