Yetunde Fadahunsi

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The U.S. Food and Drug Administration (FDA) has issued draft guidance on its “Platform Technology Designation Program,” which aims to streamline drug development, manufacturing, and marketing application review for products using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.

May 22, 2024 | jdsupra.com | Michael Druckman |Yetunde Fadahunsi

FDA has recently increased its efforts to support the development and approval of cell, tissue, and gene therapy (CTGT) products. This is evidenced by the upswing in CTGT approvals in the last few years and the unprecedented approval, on the same day in 2023, of a novel gene editing product and another gene therapy product for sickle cell disease.

May 6, 2024 | lexology.com | Jodi Scott |Lowell Zeta |Blake Wilson |Randy Prebula |Brooke Bumpers |Suzanne Friedman | +2 more

The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs). Below we summarize the most notable changes between the proposed rule and Final Rule, including the grandfathering provision and inclusion of more carve-outs for categories of tests that will continue to receive enforcement discretion.

Mar 11, 2024 | lexology.com | Heidi Forster Gertner |Bill Ferreira |Randy Prebula |Yetunde Fadahunsi |Will Tenbarge

As part of its broader efforts to improve the informed consent process for prospective study participants, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) published new draft guidance on how to present key information at the beginning of an informed consent document.