FDA Regulatory

Key FDA updates on generative AI, medical product user fees, SEC coordination, GLP-1 drug shortages, and the future of diagnostic testing.

The August 2026 edition of FDA in Flux highlights significant developments shaping the regulatory landscape for the medical, life sciences, and consumer product sectors.

The June 2026 edition of FDA in Flux highlights significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors.

The May 2026 edition of FDA in Flux highlights significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors.

The April 2026 edition of FDA in Flux highlights significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors.

The March 2026 edition of FDA in Flux highlights significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors.

The February 2026 edition of FDA in Flux highlights significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors.

The January 2026 edition of FDA in Flux highlights significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors.

The December 2025 edition of FDA in Flux highlights significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors.

The November 2025 edition of FDA in Flux highlights significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors.

The October 2025 edition of FDA in Flux highlights significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors.

The September 2025 edition of FDA in Flux highlights significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors.

The August 2025 edition of FDA in Flux highlights significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors. Responding to President Trump’s executive order on reducing regulatory burdens, FDA announced the PreCheck program, with the goal of accelerating onshoring of drug manufacturing. FDA, HHS, and USDA have issued a joint request for data and information to develop a uniform definition of ultra-processed foods (UPF). FDA held a public meeting on August 4 to start negotiation for reauthorizing the Medical Device User Fee Amendments (MDUFA), providing a look at what stakeholders hope to achieve in terms of FDA commitments and performance goals. In July, FDA announced that it is revoking 52 individual “obsolete and unnecessary” food product standard-of-identity (SOI) regulations.

A July 14, 2025 U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder that medical device requirements cannot be waived or overlooked merely because a company advertises the product for wellness and lifestyle purposes. The advisory action also indicates that FDA’s Center for Devices and Radiological Health (CDRH) remains steadfast in its enforcement of device regulations despite ongoing changes in other centers and throughout the agency.

The July 2025 edition of FDA in Flux highlights five significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors.

Of Counsel Bridgette Keller is joined by Joanne Hawana, Ben Zegarelli, and John Daley, as they offer advice for navigating communications with the FDA.

Welcome to FDA in Flux – A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.

The obvious result of the legal shootout between the U.S. Food & Drug Administration (FDA) and clinical laboratory trade associations, the American Clinical Laboratory Association and the Association for Molecular Pathology, in the Eastern District of Texas to determine whether the Federal Food, Drug, and Cosmetic Act (FD&C Act) permits the agency to regulate laboratory developed tests (LDTs) is a complete victory for clinical laboratories. The U.S. district judge’s decision, issued on March 31, 2025, vacated the May 2024 final rule through which FDA sought to specify that LDTs are agency-regulated in vitro diagnostic products (IVDs) and to describe a plan for phasing-in enforcement of existing medical device regulations for such products over four years (see our previous posts on the LDT final rule here and here). In adopting the plaintiffs’ arguments wholesale, however, the judge created some incongruities in the relevant regulatory frameworks, as well as several quandaries for FDA and the clinical laboratory industry going forward. These inconsistencies could have greater consequences down the road if the Trump administration decides not to appeal the ruling.