Drugs
A bipartisan group of four House members is asking FDA commissioner Robert Califf to tell what steps the agency is taking to counter potential issues associated with drug companies conducting trials with medical centers and hospitals associated with China’s People’s Liberation Army (PLA). The letter says such trials
Drugs
A 1/22-2/2 FDA inspection at the Eugia Pharma Specialties Limited drug manufacturing facility in Hyderabad, Telangana, India, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/15 Warning Letter says specific violations were: * failure to ensure that laboratory records included complete
Devices
The Association for Molecular Pathology and a doctor described as a “world-renowned clinical pathologist” who chairs the Department of Pathology at the University of Texas Medical Branch-Galveston, are suing FDA in a Texas federal court to block implementation of the agency’s final rule on laboratory-developed tests
Drugs
Eli Lilly is reporting “positive topline results” from its SURMOUNT-1 three-year study that assessed tirzepatide (weight-loss drug Zepbound and Type 2 diabetes drug Mounjaro) for long-term weight management and delay in progression to diabetes in adults with pre-diabetes and obesity. “Weekly tirzepatide injections (5 mg,
Drugs
Hyman, Phelps & McNamara senior medical device regulation expert Veronique Li and attorney Jeffrey Gibbs say FDA needs to improve its posting of de novo decision summaries. Writing online in their firm’s FDA Law Blog, Li and Gibbs say that whenever the agency grants a de novo request, it
Devices
ICU Medical is expanding a Class 1 recall of its Plum 360, Plum A+ and Plum A+3 Infusion Systems to update the use instructions due to a manufacturing defect with the batteries, which can result in diminished battery life. The updated notice expands affected products from a 3/2023
Drugs
FDA has granted ReAlta Life Sciences orphan drug and fast track designations for RLS-0071 and its use in treating hospitalized patients with steroid-refractory acute graft-versus-host disease (aGvHD). The serious and often fatal complication occurs after hematopoietic stem cell transplantation when the donor's immune cells
Devices
CDRH has granted a de novo marketing authorization for SoClean’s 3+ Bacterial Reduction Device, an over-the-counter product intended to be used as an adjunct to reduce bacterial populations on certain compatible home-use continuous positive airway pressure masks and ventilation hoses after cleaning. An agency classification (Class
Drugs
FDA has granted Daiichi Sankyo and AstraZeneca a breakthrough therapy designation for Enhertu (fam-trastuzumab deruxtecan-nxki) for treating unresectable or metastatic hormone receptor-positive HER2 low or HER2 ultralow breast cancer patients who have received either two lines of endocrine therapy in the metastatic setting, or one line of
Drugs
FDA has lifted a partial clinical hold on a MediLink Therapeutics and BioNTech Phase 1 trial evaluating BNT326/YL202 (NCT05653752), a HER3-targeted antibody-drug conjugate for treating EGFR-mutated non–small cell lung cancer and hormone receptor–positive, HER2-negative breast cancer. The hold was in response to study
Drugs
FDA has posted a final guidance entitled “Product-Specific Guidance (PSG) Meetings Between FDA and ANDA Applicants Under GDUFA.” The document provides recommendations on meetings between FDA and a prospective applicant preparing to submit or has already submitted an ANDA. It includes information about requesting and conducting PSG meetings with
FDA Policy/General
Federal Register notice: FDA is announcing a 9/20 Vaccines and Related Biological Products Advisory Committee to discuss controlled human infection models in pivotal studies to demonstrate pertussis vaccine efficacy. Panel members will also hear an overview of CBER’s laboratory of mucosal pathogens and cellular immunology research program. To
Drugs
FDA has denied a United Therapeutics citizen petition that asked it to withdraw tentative approval of a Liquidia Technologies NDA for Yutrepia (treprostinil) and issue a complete response letter instead. The 5/10 petition said that LGM Pharma, which United says is Liquidia’s sole active pharmaceutical ingredient (API) supplier,
Devices
FDA has cleared a Guard Medical 510(k) for additional large sizes of surgical incision closures (wounds up to 25cm) for treatment with its next-generation negative pressure wound therapy (NPWT) dressing, NPseal. The surgical dressing uses an integrated pump that establishes and maintains negative pressure with just a few
FDA Policy/General
Federal Register notice: FDA is classifying into Class 2 devices that are intended to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS–CoV–2 respiratory infection, and other microbial agents when in a multi-target test. To view the notice, click here.
Devices
FDA has granted a de novo marketing authorization to NOWDiagnostics for its First To Know Syphilis Test, an at-home, over-the-counter test for detecting syphilis (Treponema pallidum) antibodies in human blood. “Results from this type of test alone are not sufficient to diagnose syphilis infection and should be
FDA Policy/General
Federal Register notice: FDA is classifying intravenous catheter force-activated separation devices into Class 2 (special controls). The action is based on Lineus Medical’s request for a De Novo classification of its SafeBreak Vascular, a device placed in line with an intravenous catheter and an intravascular administration set, including
FDA Policy/General
Federal Register notice: FDA is classifying into Class 2 devices that are intended to detect and identify selected microbial agents that cause acute febrile illness. The action is based on a BioFire Defense request for De Novo classification of its FilmArray Global Fever Panel, which is intended to aid in
Devices
FDA has issued iRhythm Technologies (San Francisco, CA) a Form FDA-483 after an inspection last month cited three GMP deficiencies. The company has been working to resolve issues raised in a Warning Letter last year, and the latest inspection presumably is a follow-up action to evaluate the company’
Devices
HHS says it is working with FDA to help resolve an ongoing supply shortage of BD’s Bactec blood culture media bottles, which could impact clinical practices for healthcare providers and laboratories. “We recommend that health care providers, laboratory professionals, and health care facility administrators prioritize and conserve BD Bactec
Drugs
FDA has approved AstraZeneca’s Imfinzi (durvalumab) with platinum-containing chemotherapy as neoadjuvant treatment that is followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors greater than 4 cm or node positive) non-small cell lung cancer (NSCLC). The drug is intended for use
Drugs
The Washington DC District Court has denied a Novartis motion for a temporary restraining order or a preliminary injunction to stay FDA’s approval of MSN Laboratories’ generic version of Novartis’s Entresto (sacubitril/valsartan), indicated for reducing the risk of cardiovascular death and hospitalization in adult patients with chronic