Erkang Ai

May 7, 2024 | jdsupra.com | Erkang Ai |Brooke Bumpers |Suzanne Friedman

FDA has finalized its landmark proposed rule that will amend the definition of “in vitro diagnostic (IVD) products” in 21 CFR § 809.3 to make explicit that IVDs are medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA), “including when the manufacturer of the IVD is a laboratory.” We previously analyzed the October 2023 proposed rule (Notice of Proposed Rulemaking (NPRM)) online here, providing background in that article on FDA’s decades-long history of exercising enforcement...

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.

Jul 19, 2023 | jdsupra.com | Erkang Ai |Randy Prebula |Blake Wilson

The pilot program aims to publish minimum performance standards for a companion diagnostic (CDx) based on the clinical trial assay’s (CTA’s) performance during the drug product’s pivotal clinical trial.

Jul 19, 2023 | lexology.com | Randy Prebula |Blake Wilson |Lowell Zeta |Erkang Ai

The U.S. Food and Drug Administration recently released the guidance “Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program,” laying out the process by which FDA will offer up to nine drug makers the chance to join a new pilot program designed to improve transparency for oncology drugs that rely on in vitro diagnostics to identify patients who may benefit from a particular treatment.