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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.

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FDA Issues Updated Draft Guidance on Use of ...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

Comment Now! Ethical Considerations in Pediatric Studies Draft Guidance

09/27/2022

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The US Food and Drug Administration (FDA) released a draft guidance “Ethical Considerations for Clinical Investigations of Medical Products Involving Children” in September 2022. The draft guidance clarifies the ethical principles for the conduct of pediatric clinical trials, including that children are a vulnerable population so additional safeguards are needed to ensure their safety. The safety of pediatric participants is covered under the FDA regulations 21 CFR part 50, subpart D, Additional Safeguards for Children in Clinical Investigations, and 45 CFR part 46, subpart D, Additional Protections for Children Involved as Subjects in Research.

Did You Know? Charging for Investigational Drugs Draft Guidance

08/31/2022

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The US Food and Drug Administration allows charging for investigational drugs that are under an investigational new drug application (IND) in certain circumstances. The “charging regulation” (21 CFR 312.8) which came into effect in October 2009, describes what costs are recoverable and circumstances where charging is permitted.

Bye Bye to Five Whys?!

08/16/2022

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Do you ever wonder why people are not doing what you expect? How do you figure out what went wrong and what constraints are getting in the way of everything working as it should? You may have heard that you need to ask the right question, or even about the Five Whys. But if you have used the Five Whys before, have you noticed that you are not confident in the results?

Input Requested on Safety for Medical Software Functions

08/09/2022

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The US Food and Drug Administration (FDA) is requesting input from stakeholders and patients on patient safety for medical software functions that are not defined as medical devices by the 21st Century Cures Act (“Cures Act”) of 2016. Some examples of these are healthy lifestyle apps, electronic medical records, and systems that display lab results.