In what these days appears to be highly unusual, a 9-0 ruling by the justices of the Supreme Court “overturned a lower court’s decision in favor of Amarin. Generic drugmakers argued that a ruling in favor of Amarin in the case would have discouraged them from making and selling their lower-cost drugs and increased U.S. […]
On June 2, 2026 in The Wall Street Journal, Charles L. Hooper and David R. Henderson wrote “…Remove efficacy from the FDA’s approval process and focus on safety alone. That would improve doctors’ ability to match patients with the best drugs and help Americans live longer, healthier lives. Medicine is a matchmaking exercise in which potentially beneficial drugs […]
Over the last week, the FDA issued a series of seven warnings about supplements that contain undeclared drugs. Six of the products contain numerous undeclared active drug ingredients including the usual suspects sildenafil, tadalafil, and testosterone propionate on the erectile dysfunction side of the house and piroxicam for relieving pain/arthritis. The seventh product, Tawon Liar, […]
Today, the FDA published a draft guidance titled “Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products: Guidance for Industry,” aimed at implementing streamlined approaches for nonclinical safety assessments of certain oncology pharmaceuticals. The draft guidance can be found here. The document provides some interesting background on the evolution of the Agency’s thinking […]
The commercial landscape for GLP-1 products is very different than for other pharmaceutical products. Demand is extremely high given the prevalence of obesity, direct-to-patient sales through social media and other channels, and public interest magnified by celebrity endorsement. When these factors overlap, pharmacovigilance (PV) activity increases quickly—and not always in predictable ways. These products are […]
In this morning’s Federal Register pre-notification page (here), the FDA announced the addition of 23 new Product-Specific Guidances (PSGs) and 48 revised PSG documents. The FDA began publishing PSGs on June 11, 2010 when it announced its first group of PSGs to assist firms in understanding the FDA’s current thinking on the bioequivalence requirements for specific […]
Through May 15, 2026, the OGD reports 26 full approval actions and 11 tentative approval actions. Given the number of actions in the first half of the month, May approval actions will likely fall well behind the April figures, even if the approval pace picks up. So, with 37 total approval actions thus far in May, […]
FDLI’s 2026 annual conference covered several industry hot topics, with a particular focus on AI and how the FDA is leveraging technology and existing resources to improve efficiency and engage with industry. Although progress appears to be on the horizon, industry should remain mindful of the FDA’s current structural limitations and the ongoing need for […]
Dr. Marty Makary resigned today as FDA Commissioner, marking another leadership transition for an agency that continues to face pressure across drug reviews, inspections, compliance, and broader public health policy. For pharmaceutical and biotech companies, changes in FDA leadership always raise questions about regulatory priorities, review timelines, and enforcement focus. While leadership shifts can influence […]
I had the good fortune to attend the FDLI Annual Meeting held on May 6th and 7th. The FDLI Annual Meeting is always a good conference where attendees are able to hear many great updates from the FDA and insights on issues related to our industry. This year was no exception, and the FDA had a […]
