Devices
FDA has warned O.N. Diagnostics that it made significant changes to its VirtuOst vertebral fracture assessment software — including a new machine-learning algorithm and conversion to a web-based platform — without obtaining required agency clearance. A just-posted 9/1 Warning Letter following a March inspection of the Berkeley,
Drugs
A new Stanford Biodesign policy paper is calling for a dozen bipartisan FDA reforms aimed at accelerating clinical trials and drug reviews, including allowing some lower-risk Phase 1 trials to begin without waiting for prior FDA approval and expanding rolling review of marketing applications. The paper, Roadmap for FDA
Biologics
MimiVax says it plans to seek a meeting with FDA to review positive results from its Phase 2b SURVIVE trial of SurVaxM, a novel cancer vaccine for patients with newly diagnosed glioblastoma. In a statement, company officials say they want to use the meeting to review the SURVIVE data and
Drugs
Biostatisticians from FDA and several universities say interest in integrating randomized clinical trials (RCTs) with real-world data (RWD) continues to grow as stakeholders seek evidence that is both internally valid and relevant to clinical practice. Writing in an open-source article in Clinical Pharmacology & Therapeutics, the researchers say,
Devices
FDA says that as of 10/7, there are 159 medical devices enrolled in the Total Product Life Cycle Advisory Program (TAP) pilot. An online update also says that on 7/1, TAP expanded to accept enrollment requests across all Offices of Health Technologies for Breakthrough-designated and Safer Technologies
Drugs
FDA and the National Institutes of Health (NIH) are “working together extremely closely” in the effort to reduce animal testing for drugs. That’s the report of NIH deputy director for program coordination, planning, and strategic initiatives Nicole Kleinstreuer, who said, “I think what we’re seeing is an unprecedented
Drugs
A review of 42,192 observations from 8,663 inspections conducted between 2008 and 2026, as shown on the FDA inspection dashboard, found that 2026 does not represent a wholesale shift in FDA inspection priorities. Rather, according to regulatory consultant Jeffrey Palmer, writing in an online post, it reflects intensified
Drugs
FDA’s decision to establish its new Office of Innovation and Clinical Trial Modernization (OICTM) and form dedicated divisions for artificial intelligence (AI) and real-world evidence (RWE) analytics (see earlier story) could provide drug developers with a clearer regulatory pathway for emerging technologies, but the agency now faces the
Drugs
A 3/9-3/16 FDA inspection at the TCI Co., Ltd BioCosme PABP Branch drug manufacturing facility in Taipei City, Taiwan, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 9/2 Warning Letter says the four specific violations were: * failure to
Devices
After working on over 25 medical device Form FDA-483s and Warning Letters for clients this year, attorneys Jodi Scott and Mike Heyl (Hogan Lovells Cadwalader) say it is clear that FDA has changed its approach to inspections under the QMSR to focus on a “holistic evaluation of quality system
Independent news and analysis of FDA regulation, policy and enforcement
FDA says its review of labeling for nine drugs it purchased from the Amazon Web site and three drugs purchased from the Walmart Web site found that the two online retailers were selling unapproved new drugs. A 10/1 Warning Letter issued to Amazon says the agency brought nine herpes
FDA has updated a BD and CareFusion removal (Class 1 recall) of certain BD Alaris Pump infusion sets after additional testing found some sets can perform significantly worse than previously disclosed, potentially causing under- or over-infusion, delayed occlusion alarms and inaccurate bolus doses. The Alaris system is used for
ArriVent BioPharma says its Phase 3 FURVENT trial of firmonertinib failed to meet its primary endpoint in previously untreated patients with EGFR exon 20 insertion-mutant non-small cell lung cancer (NSCLC), raising concern about the drug’s development path. The pivotal trial compared two doses of firmonertinib — 160 mg
FDA should strengthen its oversight and enforcement of confirmatory trials for accelerated approval drugs, with Medicare and Medicaid payments limited until the products’ clinical benefits are confirmed, according to a new proposal for expanding the agency's role in addressing drug costs. The proposal is one of several recommendations
Recent FDA enforcement activities could signal increased scrutiny of telehealth platforms that facilitate prescribing of compounded drugs, particularly when technology or standardized processes may undermine individualized clinical decision-making, according to attorneys at ArentFox Schiff. In an 10/5 Insights post, attorneys Abha Kundi and Matthew Berlin noted FDA'
An artificial intelligence (AI) model detected pancreatic cancer on routine CT scans more than a year before clinical diagnosis and substantially outperformed expert radiologists in identifying early cancers that were not yet visually apparent, according to a study published in BMJ’s Gut. Researchers led by Mayo Clinic developed a
Misinformation on TikTok linking acetaminophen use during pregnancy with autism surged following a 9/2025 FDA announcement (see story) on the issue, with misleading videos attracting disproportionate attention, according to research presented at the American Academy of Pediatrics' 2026 National Conference & Exhibition. Researchers analyzed 53 TikTok videos posted
Senate Aging Committee chairman Rick Scott (R-FL) is raising concerns about Chinese medical device manufacturers seeking to enter the U.S. market, warning that devices capable of collecting patient information could pose cybersecurity and health-data risks. In a 10/2 letter to CMS administrator Mehmet Oz, Scott specifically
FDA is seeking public input on potential early-phase clinical trial designs for ibogaine drugs, including proposals for cautious dose escalation, intensive cardiac and neurologic monitoring and independent safety oversight. In a request for information (RFI), CDER says it is seeking comments and data on appropriate patient populations, dosing, care
FDA has granted Eli Lilly an orphan drug designation for olomorasib as a monotherapy for treating adult patients with advanced pancreatic cancer who have received at least one prior systemic therapy and have a KRAS G12C mutation, as determined by an FDA-approved test. Olomorasib is described as an investigational,
Stoke Therapeutics says it has reached agreement with FDA on key elements of a planned NDA submission for zorevunersen, an investigational antisense oligonucleotide for Dravet syndrome. The company says it is targeting a submission in the the second half of 2027. A recent FDA and company meeting covered five years
FDA has unveiled a new Transparency Roadmap that calls for expanded public disclosure of complete response letters, clinical study reports, inspection records and other regulatory information as part of a broader fiscal year 2027 transparency initiative. The roadmap builds on FDA’s 2025 initiative to publicly release complete response letters