No Appeal of LDT Decision Means Ball Is Back in FDA’s Court for Policy Clarification

On August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary. After an independent safety review of fluoropolymers in medical devices showed no conclusive evidence of health issues, FDA concluded that fluoropolymers are “very unlikely to cause toxicity” because of molecular size and further that they are essential for medical devices to function. As a result, “FDA’s evaluation is that currently there is no reason to restrict their continued use in devices.” This announcement will be a source of relief to the device and diagnostics industries.

On July 25, the U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA), unveiled the highly anticipated joint request for information on ultra-processed foods (UPFs). Specifically, the administration is seeking information and data to help develop a uniform definition for UPFs in the U.S. food supply.

Dr. George Tidmarsh has been selected to replace Dr. Jacqueline Corrigan-Curay as the director of the Center for Drug Evaluation and Research (CDER) at FDA as she prepares to retire from the agency. Dr. Tidmarsh is an adjunct professor of pediatrics and neonatology at Stanford University and is credited as having been involved in the development of several approved drugs. Until late May of this year, Dr. Tidmarsh was a member of the board of directors of Revelation Biosciences, a company engaged in developing an anti-inflammatory IV therapy. Among other roles and experiences he has had, he was a founding Co-Director of Stanford’s Master of Science in Translational Research and Applied Medicine (M-TRAM) program, and founded Horizon Pharma in 2005.

Recently, it was reported that the U.S. Food and Drug Administration (FDA) is launching two cross-agency artificial intelligence (AI) councils. One AI council will be tasked with addressing how the agency uses AI internally and the other will focus on policy governing AI’s use in FDA-regulated products (reportedly pre-existing AI councils in various FDA divisions will continue to operate) (Politico Pro).

This week, the U.S. Food and Drug Administration (FDA) granted another color additive petition, approving the use of Gardenia (Genipin) in various food and beverage products. This marks the fourth naturally-derived color additive authorized for use in foods since FDA’s April announcement to phase out all petroleum-based synthetic dyes in food and transition to natural alternatives (read more here). Gardenia blue, derived from the fruit of the gardenia, a flowering evergreen, is now approved for use in sport drinks, flavored or enhanced non-carbonated water, fruit drinks and ades, ready-to-drink teas, hard candy and soft candy.

This morning, the U.S. Food and Drug Administration (FDA) announced the publication of more than 200 decision letters, also known as complete response letters (CRLs), with plans to release more from the archives. The CRLs released today are associated with applications for drugs and biologics submitted for approval between 2020 and 2024 that have since been approved by the agency.

On June 24, 2025, in a hearing before the U.S. House of Representatives Committee on Energy and Commerce, the Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr. revealed that his department plans to soon launch an advertising campaign encouraging Americans to use wearable health devices. The campaign is set to be “one of the biggest advertising campaigns in HHS history.”

On June 17, 2025, the U.S. Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a new program that aims to speed up drug application review for companies aligned with U.S. national priorities. In terms of qualifying for the program, the key differentiator between this program and other “priority” review programs is that the application must support increased domestic drug manufacturing—presumably meaning that the applicant commits to manufacture the drug in the United States. The key benefit is that drug developers can redeem the vouchers to accelerate their application review time from 10-12 months to one to two months after a sponsor’s final drug application submission. The program includes enhanced communication with the sponsor and will utilize a team-based review process, in which a multidisciplinary team of FDA experts, who will prereview clinical information, gather for a one-day “tumor board style” meeting. While some of the review work is envisioned to be “front loaded” before the actual application is submitted, it is still the case that a two-month review window would be a radical acceleration of the review timeline compared to standard review times.