Devices
FDA’s recent discussion paper (see earlier story) on regulating generative AI (GenAI) medical devices could increase regulatory scrutiny for user-facing GenAI-enabled devices, according to an analysis by law firm Crowell & Moring, which says the agency may need to rethink traditional approaches to evaluating medical software. FDA
Drugs
FDA has approved Ionis Pharmaceuticals’ Zanvastro (zilganersen) injection for treating Alexander disease in pediatric and adult patients — the first approved treatment for the disease and the first therapy to directly target the protein buildup that causes it. The rare, progressive neurological disorder is caused by mutations in the gene that
FDA Policy/General
Opposition to FDA commissioner nominee Heidi Overton is mounting, as a letter-writing campaign is underway to block Senate confirmation over her involvement with the Make America Healthy Again agenda, among other issues. “The FDA regulates the vaccines, medications, medical devices, food and other products Americans rely on every day,
Drugs
FDA has granted AstraZenenca an accelerated approval for Etcamah (camizestrant), an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. The approval applies to
Devices
FDA has granted Heartvue.ai a 510(k) clearance (K260811) for its Heartvue.Proton, a machine learning–powered software for viewing, post-processing, and quantitative evaluation of cardiovascular magnetic resonance images (MRI). Cardiac MRI is the gold standard for assessing cardiac structure and function, but manual analysis can take up
Drugs
AbbVie is reporting “positive topline results” from the Phase 3 CERVINO study evaluating etentamig, an investigational BCMA x CD3 bispecific T-cell engager, versus standard available therapies (SAT) in patients with triple-class exposed (proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody) relapsed/refractory multiple myeloma (RRMM). CERVINO met
enforcement
CDRH has issued an early alert based on a Draeger letter to customers recommending certain VentStar Resus Neo hoses (breathing circuits) be removed from where they are used or sold. Draeger stated that they are aware of cases in which obvious cracks in the hose were detected by the users
Devices
Boston Scientific has recalled (Class 1) all unused spinal cord stimulator Infinion CX Leads after determining that the lead body may experience mechanical stress at the anchor site, which may result in high impedance measurements or lead fractures. “Abnormal impedance measurement may lead to inadequate stimulation and/or additional intervention,
FDA Policy/General
Peter Barton Hutt, former FDA chief counsel who was widely known as the "Dean of the Food and Drug Bar," died on 9/2 at the age of 91. Hutt spent more than six decades shaping the legal and regulatory framework governing drugs, medical devices, foods and other
Drugs
The consulting firm RMS says its analysis of over 300 complete response letters (CRLs) posted by FDA since 2025 shows that the most effective strategy for coping with CRL risk is prevention. Writing in the Real Economy blog, RMS says, “Companies that identify and resolve potential regulatory, quality, and manufacturing
enforcement
Senate Special Committee on Aging chairman Rick Scott (R-FL) and ranking member Kirsten Gillibrand (D-NY) are asking the Government Accountability Office (GAO) to analyze the connection between foreign drug manufacturing and drug recalls. In their letter to the GAO, the senators said, “Over the past three decades, the
Drugs
FDA is seeking public input and comments on its efforts to advance the development of botanical drug products (BDPs). A Federal Register notice to be published on 9/4 says the agency wants to “better understand stakeholders’ perspectives on the state of BDP development in the U.S., challenges encountered,
Drugs
Writing in an FDA Voices column, four senior agency executives describe ways in which FDA is strengthening its oversight of good clinical practice (GCP) as the ethical and scientific foundation for clinical investigations of all regulated products. The column was written by CDER acting director Michael Davis, CBER acting director
Drugs
The American Society of Gene & Cell Therapy (ASOCT) says an FDA draft guidance on leveraging prior knowledge in developing human gene therapy products incorporating genome editing would have greater value if it applied more broadly across cell and gene therapy modalities and provided greater clarity about how knowledge accumulated
Drugs
CBER has published a Standard Operating Policy and Procedure (SOPP), Complying with Requirements Under the Pediatric Research Equity Act (PREA) & Best Pharmaceuticals for Children Act (BPCA), as a resource to ensure that sponsors/applicants and CBER staff follow the required procedures and timeframes under the two laws. The SOPP
Drugs
A Friends of Cancer Research (Friends) white paper proposes a fit-for-purpose approach to support administered activity escalation and dosage optimization in radiotherapeutic therapy (RPT) development. Friends says its approach is based on these core principles: * use escalation to generate RPT-specific evidence; * anchor decisions to the totality of
Drugs
CDRH has issued an alert on AVID Medical convenience kits based on a letter the company sent to customers recommending that certain kits be corrected prior to continued use by removing components affected by the earlier Huons Co., Ltd. recall. The Center says users should not use sodium chloride ampules
Biologics
uniQure has submitted a BLA seeking accelerated approval of ifezuntirgene inilparvovec (AMT-130), an investigational gene therapy for treating Huntington’s disease. The company’s submission requested a priority review. The filing is based on a three-year data analysis from a Phase I/II clinical study of ifezuntirgene inilparvovec,
Drugs
FDA has ordered a Boxed Warning for American Regent’s Injectafer (ferric carboxymaltose injection) over the risk of symptomatic hypophosphatemia, a potentially serious condition in which phosphate levels in the blood become abnormally low. The warning recommends monitoring blood phosphate levels in patients considered at risk for the condition, as
enforcement
A 4/13-4/17 FDA inspection at the Shoolin Pharma Chem drug manufacturing facility in Mehsana, Gujarat, India, found that the company manufactures active pharmaceutical ingredients (APIs) under insanitary conditions and with significant deviations from current good manufacturing practice (CGMP) regulations for APIs. An 8/18 Warning Letter says
Drugs
FDA has released a draft guidance entitled Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage. The document is intended to assist sponsors in their design and analysis of studies that assess the influence of impaired hepatic function (hepatic impairment (HI)) on the pharmacokinetics
Devices
FDA has released two guidance documents on dental-related medical devices. The one guidance, Dental Curing Lights – Premarket Notification (510(k)) Submissions, provides recommendations for 510(k) submissions for dental curing lights that emit non-ionizing optical radiation intended to photopolymerize dental restorative resins. FDA is issuing this guidance to