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Oct 10, 2024 | 
jdsupra.com | Stephanie Agu |Robert Church |Ashley Grey
The U.S. Food and Drug Administration (FDA) finalized its revised guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical investigations to account for advances in digital health technologies (DHTs).
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Oct 9, 2024 | 
lexology.com | Robert Church |Blake Wilson |Alex Smith |Stephanie Agu |Ashley Grey
Digital Health Technology oversight remains paramountThe U.S. Food and Drug Administration (FDA) finalized its revised guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical investigations to account for advances in digital health technologies (DHTs).
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Oct 9, 2024 | lexology.com | Robert Church |Blake Wilson |Alex Smith |Stephanie Agu |Ashley Grey
Digital Health Technology oversight remains paramountThe U.S. Food and Drug Administration (FDA) finalized its revised guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical investigations to account for advances in digital health technologies (DHTs).
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Jul 1, 2024 | 
jdsupra.com | Stephanie Agu |Deborah Cho |Robert Church
The Food and Drug Omnibus Reform Act of 2022 (FDORA) amended the Federal Food, Drug, and Cosmetic Act (FDCA) to require drug and device sponsors to submit diversity action plans (DAPs) for the stated purpose of increasing enrollment of subjects from historically underrepresented populations, which the agency believes will help the strength and generalizability of clinical evidence.
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Feb 21, 2024 | 
jdsupra.com | Stephanie Agu |Robert Church |Heidi Forster Gertner
FDA recently issued a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring Committees in Clinical Trials.”When finalized, this guidance will replace the 2006 final guidance on the same topic entitled “Establishment and Operation of Clinical Trial Data Monitoring Committees.” A DMC[1] is a group of experts that reviews accumulating data from one or more ongoing clinical trials in order to monitor the continuing safety of trial...
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Feb 21, 2024 | 
lexology.com | Robert Church |Heidi Forster Gertner |Blake Wilson |Stephanie Agu |Eva Schifini
Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring Committees in Clinical Trials.” In the Federal Register notice announcing the draft guidance, FDA explained that there has been “an increase in the use of DMCs in many disease areas not involving serious morbidity or mortality.” Among other things, FDA noted that DMCs can provide specialized expertise to evaluate...
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Feb 19, 2024 | 
jdsupra.com | Stephanie Agu |Heidi Forster Gertner |Blake Wilson
FDA originally published final guidance on the collection of race and ethnicity data in clinical trials in 2016, in response to the Office of Management and Budget (OMB) Statistical Policy Directive 15, Revisions to the Standards for the Classification of Federal data on Race and Ethnicity, which was developed to provide a common framework for uniformity and consistency in the collection and use of data on race and ethnicity by federal agencies.
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Feb 17, 2024 | 
lexology.com | Stephanie Agu |Heidi Forster Gertner |Blake Wilson |Eriko S. Yoshimaru
The U.S. Food and Drug Administration (FDA) continues its efforts to include diverse participants in clinical research with a newly-published revision to its draft guidance document entitled, “Collection of Race and Ethnicity Data in Clinical Trials,” which provides recommendations on the standardized collection of race and ethnicity data.
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Dec 11, 2023 | 
jdsupra.com | Stephanie Agu |Deborah Cho |Robert Church
FDA’s latest two-day workshop was aimed at promoting diversity in clinical trial enrollment and patient participation to reflect the demographic subgroups represented in the disease/condition being studied. Academics, industry stakeholders, and the Directors of the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH) offered suggestions for enhancing clinical trial diversity.
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Aug 22, 2023 | 
jdsupra.com | Stephanie Agu |Eman Al-Hassan |Deborah Cho
FDA regulations require clinical trial sponsors to present information from premarket studies on the safety and effectiveness of drugs and biologics in terms of gender, age, and racial subgroups. However, if certain patient populations are not adequately represented in premarket clinical trials, FDA may also require or request collection of such data in the postmarketing setting.
