-
Jan 14, 2025 | 
jdsupra.com | Eman Al-Hassan |Robert Church |Heidi Forster Gertner
FDA defines a protocol deviation as a “generally unintentional” departure from IRB-approved protocol, noting they are commonly not discovered until after they occur. For example, an investigator’s failure to perform a protocol-required test being discovered by the study monitor during a routine monitoring visit would be a protocol deviation.
-
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.
-
Nov 14, 2024 | 
jdsupra.com | Eman Al-Hassan |Sanchita Bose |Robert Church
November 14, 2024 Eman Al-Hassan, Sanchita Bose, Robert Church, Heidi Forster Gertner, Ashley Grey, 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, Evelyn Tsisin] The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed consent practices. Below, we summarize key takeaways from the meeting,...
-
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...
-
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).
-
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).
-
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).
-
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.
-
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.
-
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.
