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Jan 22, 2025 | 
jdsupra.com | Melissa Bianchi |Ashley Grey |Bert Lao
The U.S. Food and Drug Administration (FDA) recently published its long-awaited draft guidance on considerations for the use of artificial intelligence (AI) to support regulatory decision-making for drug and biologics, which provides a comprehensive, risk-based framework to help sponsors evaluate and manage AI models.
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Jan 14, 2025 | 
jdsupra.com | Robert Church |Ashley Grey |Wil Henderson
[co-author: Lauren Massie]U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product development, clinical research, and clinical care, which we summarized here.
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Oct 22, 2024 | 
jdsupra.com | Melissa Bianchi |Robert Church |Ashley Grey
October 22, 2024 Melissa Bianchi, Robert Church, Ashley Grey, Wil Henderson, Bert Lao, Melissa Levine, Jodi Scott, Blake Wilson Hogan Lovells + Follow x Following x Following - Unfollow Contact To embed, copy and paste the code into your website or blog: [co-author: Lauren Massie] Last week, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials published a “Special Communication” in JAMA titled, “FDA Perspective on the Regulation of...
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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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Aug 7, 2024 | 
jdsupra.com | Jason Conaty |Ashley Grey |Randy Prebula
“Combination products” are comprised of two or more different types of products (i.e., a combination of a drug, device, and/or biological product).
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Aug 7, 2024 | 
lexology.com | Randy Prebula |Jason Conaty |Eva Schifini |Ashley Grey
The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name from 2005. The revision modernizes the guidance to align it with current user fee program expectations.
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Jun 4, 2024 | 
jdsupra.com | Robert Church |Michael Druckman |Ashley Grey
FDA developed the new platform technology designation program draft guidance to fulfill its requirement under Section 506K(b) of the Federal Food, Drug, and Cosmetic Act (FDCA), codified at 21 USC 356k, which was passed as part of the “PREVENT Pandemics Act” in December 2022.
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Jun 4, 2024 | 
lexology.com | Robert Church |Mike Druckman |Yetunde Fadahunsi |Bryan Walsh |Ashley Grey
The U.S. Food and Drug Administration (FDA) has issued draft guidance on its “Platform Technology Designation Program,” which aims to streamline drug development, manufacturing, and marketing application review for products using “platform technologies.” In the article below, we summarize FDA’s newly-clarified criteria for a platform technology designation, what to include in submission requests, when to submit those requests, and the potential benefits of platform technology designation.
