JONES DAY TALKS®: The CNPV Pilot Program: FDA's High-Speed Lane for Drug Approval
Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Key Takeaways - The Food & Drug Administration issued a Warning Letter citing a drug company for inappropriate use of AI in pharmaceutical manufacturing, marking what appears to be the first time the agency has specifically...more
Key Takeaways - FDA has proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list....more
This article provides an overview of the regulatory regime and associated intellectual property rights for veterinary drug products and provides an update on recent issues, focusing on features that differ from drugs for...more
Following the U.S. Food and Drug Administration's (FDA) April 2025 roadmap to reduce reliance on animal testing in preclinical safety studies, which stated that it would develop pathways for both qualification and validation...more
Peptides have quickly become one of the fastest-growing and most talked-about segments of the healthcare market, fueling weight loss clinics, performance medicine, and a $740B longevity market. But as demand accelerates, the...more
A recently issued Food and Drug Administration (FDA) Warning Letter citing a drug manufacturer for improper use of artificial intelligence (AI) suggests FDA’s scrutiny of AI is expanding. Although not the first FDA Warning...more
FDA is fighting a bootleg GLP-1 epidemic. The dangers to U.S. consumers are immediate and real. The outcome of FDA’s battle is unknown....more
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
Medical spas continue to expand beyond traditional aesthetic services, and peptides have quickly become one of the more heavily marketed offerings in this space. While these products are often positioned as part of a broader...more
This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more
The U.S. Food and Drug Administration’s (FDA) Human Food Program (HFP) has prepared a list of priority research, data, and method needs that, if fulfilled, will help FDA better understand the underlying factors that may cause...more
In its March 2026 draft guidance, the US Food and Drug Administration (FDA) outlined its current thinking on how drug and certain product manufacturers should approach Form 483 responses to inspectional observations issued at...more
Consumer demand for GLP‑1 drugs such as Ozempic and Zepbound continues to surge, fueling rapid growth in the market for GLP-1 drugs and compounded GLP-1 products, as well as supplements that are marketed to have similar...more
The market for food and beverage products containing hemp-derived cannabidiol (CBD) continues to grow. With new CBD products introduced to the market every year, here are some of the top considerations for companies looking...more
The Make America Healthy Again (MAHA) movement has already prompted notable changes in federal and state food policy and has prompted regulators, plaintiff’s lawyers, manufacturers, retailers, and consumers to take a fresh...more
FDA's approach to regulating weight-loss devices has evolved for more than a decade. In final guidance published in March 2026, FDA brings together clinical and non-clinical recommendations in a single document, retains the...more
At the outset of 2026, FDA announced a series of “priority deliverables” for 2026 as part of its Human Foods Program’s (HFP) “critical role in implementing the Trump Administration and HHS Secretary Robert F. Kennedy, Jr.’s...more
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....more
While there is a newfound awareness of per- and polyfluoroalkyl substance (PFAS) exposure and its consequences in humans, a new study found that through pet food, dogs and cats may also be exposed to PFAS. A study was...more
Denial of a motion to dismiss a "cage free" eggs lawsuit, updates on marketing plant-based products with meat- and dairy-related terms in Europe, dismissal of a lawsuit alleging a restaurant's salsa was excessively spicy, and...more
Key Takeaways - FDA explains what must be “new” to qualify for three years of non-patent market exclusivity. In a new draft Q&A guidance, FDA walks sponsors through what makes a clinical investigation “new,” how to support...more
THC beverages, zero-proof spirits, dealcoholized wines, non-alcoholic (NA) beer, kava and kratom drinks and functional wellness beverages are filling more shelves than ever at package and liquor stores, groceries, bodegas,...more
On February 5, 2026, the Food and Drug Administration (FDA) took another step to incentivize manufacturers to comply with the administration’s efforts to phase-out artificial petroleum-based color additives from the nation’s...more
The Consolidated Appropriations Act, signed into law on February 3, 2026, avoided another government shutdown. But notably for the US Food and Drug Administration (FDA) and drug developers, it also codified FDA’s...more
In one of the most aggressive regulatory shake-ups in modern pharmaceutical history, the Commissioner's National Priority Voucher Pilot Program, or CNPV, can dramatically reduce approval times for new drug introductions....more