Drugs
Failures to establish or follow written quality procedures and inadequate investigations of manufacturing problems were the most frequently cited deficiencies in FDA drug-quality inspections conducted during 2026, according to an FDA Webview analysis of agency inspection data. FDA cited deficiencies involving written quality-unit procedures in 74 inspections, representing
Devices
Risk-management deficiencies and inadequate corrective action procedures were the most frequently recorded problems in FDA medical device inspections conducted under the agency's new Quality Management System Regulation (QMSR), according to an FDA Webview analysis of 2026 inspection data. FDA cited failures to document risk-management processes associated
FDA Policy/General
FDA has begun releasing large batches of Form FDA-483 inspection reports under its expanded transparency initiative (see earlier story), but a significant limitation in the agency's online FOIA Electronic Reading Room makes it difficult for users to identify newly posted documents: the database does not allow records
Drugs
Brand-name and generic drug manufacturers are urging FDA to revise its proposed guidance (see earlier story) on determining whether sponsors should submit an ANDAor a 505(b)(2) application, with the two industry groups emphasizing different concerns about the agency's interpretation of the approval pathways. In separate
FDA Policy/General
As the Trump administration considers an interim policy allowing compounding pharmacies to produce certain unapproved peptides, a public health advocacy group is warning that expanding access to the substances could undermine FDA's drug approval process and expose consumers to potentially unsafe products. The potential policy follows a July
Biologics
FDA has accepted for priority review a Merck BLA for sacituzumab tirumotecan (sac-TMT), an investigational TROP2-directed antibody-drug conjugate (ADC), for adults with endometrial cancer previously treated with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor, administered separately or in combination. The agency has set
Devices
FDA's recent Warning Letter to O.N. Diagnostics raises questions about whether the agency is applying an overly expansive interpretation of when software modifications require a new 510(k), according to a new legal analysis. In a 10/26 FDA Law Blog article, attorney Jennifer Newberger examines the
Biologics
FDA has approved AbbVie’s subcutaneous (SC) induction regimen for Skyrizi (risankizumab-rzaa) for adults with moderately to severely active Crohn's disease (CD). “Patients now have the option to start SKYRIZI treatment at home, with induction doses delivered by an on-body injector (OBI) induction pack and then
Drugs
BreakBio, a biotechnology company developing personalized cancer immunotherapies, has appointed former FDA Commissioner Stephen M. Hahn, who led the agency from 12/2019 to 1/2021 during the first Trump Administration, as an advisor. The company says Hahn will advise BreakBio on clinical development, regulatory strategy, oncology, platform development and
FDA Policy/General
FDA has accelerated the public release of Form FDA-483 inspection records as part of its expanded transparency initiative (see earlier story), increasing the volume of inspection documents available through the agency's FOIA Electronic Reading Room. On 10/23, the agency published 26 Form FDA-483 records covering
Independent news and analysis of FDA regulation, policy and enforcement
A citizen petition filed by Foley & Lardner urges FDA to require mandatory monthly immunoglobulin monitoring and explicit treatment-interruption instructions in the prescribing information for Vertex Pharmaceuticals' investigational IgA nephropathy treatment povetacicept, ahead of an 11/30 user fee review action target date. The 10/21 petition contends
Bristol Myers Squibb reported preliminary safety and efficacy data from a Phase 1 study of its investigational CAR T-cell therapy zolacabtagene autoleucel (zola-cel; BMS-986353) in patients with multiple sclerosis, but disclosed that one trial participant died of septic pneumonia 44 days after receiving treatment. The death reportedly
If vaccine advocates gain substantial support in Congress following next month’s midterm elections, the Trump administration could still accelerate changes to federal vaccine policies in 2027, potentially limiting the effectiveness of congressional oversight, two former federal health policy officials warn. In a 10/20 MedPage Today commentary, Steven Grossman,
An FDA analysis of digital health technology (DHT) use in drug development found that electronic diaries and patient-reported outcomes accounted for the largest share of qualifying regulatory submissions, while sensor-based technologies were concentrated in a relatively small number of therapeutic areas. The study, published in Clinical and Translational
Texas has negotiated a $45 million settlement with Gilead Sciences to resolve claims that the company engaged in an illegal kickback scheme that improperly influenced prescriptions paid for by Texas Medicaid. The settlement follows a 10/2023 state lawsuit alleging that Gilead engaged in “unlawful marketing practices that were designed
Merck and Moderna are reporting positive recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) results from a highly anticipated Phase 3 trial evaluating their personalized cancer vaccine, intismeran autogene, in combination with Keytruda (pembrolizumab). The Phase 3 INTerpath-001 trial is evaluating intismeran autogene, an investigational mRNA-based
FDA's expanding transparency initiative could significantly change how pharmaceutical and biotechnology companies evaluate potential acquisitions, giving buyers greater access to regulatory information that could influence asset valuations, purchase agreements and the allocation of financial risk, according to attorneys at Arnall Golden Gregory (AGG). Earlier this month, FDA unveiled
BDR Pharmaceuticals International has filed a lawsuit against FDA, alleging the agency unlawfully extended market exclusivity for Phathom Pharmaceuticals’ acid-suppressing drug Voquezna (vonoprazan), preventing BDR from submitting an ANDA for a generic version until 5/2032. In a 10/21 complaint filed in the U.S. District Court for
The Partnership for Safe Medicines (PSM) has filed a citizen petition urging FDA to ban compounding of unapproved peptides and to disregard the advisory committee vote that recommended allowing them. The advocacy group contends the committee was constituted in violation of the Federal Advisory Committee Act and the Ethics in
A new analysis by Hogan Lovells finds CDER enforcement activities are “substantially larger, broader in scope, and more centralized than they were two years ago. Moreover, the composition of enforcement activity has shifted in ways that should prompt pharmaceutical manufacturers to reassess their compliance risks.” Examining CDER Office of Compliance’
FDA is alerting health care providers about an import alert for certain Olympus Medical Systems medical devices manufactured in Japan. “Despite extensive and ongoing efforts to address compliance issues, the FDA continues to have concerns related to outstanding Quality System regulation violations by Olympus,” the agency says. “Therefore, the FDA
FDA granted traditional approval to Merck’s Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) for certain patients with unresectable or metastatic tumor mutational burden-high (TMB-H) solid tumors, while raising the biomarker threshold used to determine eligibility for treatment. The approval covers adult and pediatric patients