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
Drugs
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
Devices
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
Drugs
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
Drugs
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
Drugs
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'
Devices
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
FDA Policy/General
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
Devices
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
Drugs
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
Independent news and analysis of FDA regulation, policy and enforcement
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
CDER has launched a new Office of Innovation and Clinical Trial Modernization (OICTM), including dedicated divisions for artificial intelligence and real-world evidence analytics. The office became operational 10/1 within CDER’s Office of Medical Policy, coinciding with the start of the new federal fiscal year. Its creation was
FDA’s Office of Prescription Drug Promotion (OPDP) has cited Evolus over an Instagram promotion for wrinkle treatment Jeuveau (prabotulinumtoxinA-xvfs), saying the post exaggerated the drug's effectiveness and onset of action while minimizing serious risks. OPDP noted that it had raised similar concerns with Evolus in 2019
FDA’s new commissioner, once confirmed and sworn in, should provide greater clarity on regulatory pathways for rare disease therapies, especially the use of single-arm clinical trials, a rare disease advocate argued in a new Washington Examiner commentary. David Gusick said uncertainty over FDA’s expectations could delay development
FDA has approved Eli Lilly’s Jaypirca (pirtobrutinib) for treating adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with no known 17p deletion. Approval was based on data from the BRUIN CLL-313 (NCT05023980) trial in 282 patients with previously untreated CLL/SLL without
FDA has extended the review of a Novo Nordisk BLA for denecimig for treating of hemophilia A, with or without inhibitors in adults and children. The agency did not provide a timeline for the extended review, according to the company. The previous user fee review action target date was set
The FDA has granted fast track status to Trethera’s TRE-515 in combination with KRAS inhibitors for certain patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC). The designation covers TRE-515 combined with KRAS inhibitors for patients with G12C mutation-positive NSCLC previously treated with an
FDA has cited Olympia Pharmaceuticals for eight observations involving aseptic processing, environmental monitoring, component testing and other manufacturing controls following an inspection last month at the company's Orlando, FL, outsourcing facility. The Form 483 said Olympia’s aseptic processing areas had deficiencies in environmental and personnel monitoring. Investigators
While FDA is stepping up scrutiny of foreign clinical trials, particularly studies conducted outside an IND (see earlier story), drug sponsors should discuss their plans to rely on foreign data with FDA early in development, including at pre-IND meetings, and put greater emphasis on site selection, monitoring, investigator training
The Committee to Protect Health Care has sent a letter signed by over 2,500 physicians to members of the Senate, urging them to reject the Trump administration’s nomination of Heidi Overton to be FDA commissioner. “Dr. Overton’s dangerous record on vaccines and extremist anti-abortion advocacy are