Drugs
American Health Packaging has recalled one lot of valsartan tablets,160 mg , due to the detection of trace amounts of an unexpected carcinogen in the finished drug product. The impurity is N-Nitrosodiethylamine, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes,
Devices
FDA has cleared a Zeiss Medical Technology 510(k) for the Cirrus HD-OCT platform, expanding the capabilities of its anterior segment premier module to include epithelial thickness mapping. The device is designed to provide a detailed nine-millimeter map of epithelial thickness for assessing patients before refractive surgery, the
Drugs
FDA has granted Genentech accelerated approval for Tecentriq (atezolizumab) plus chemotherapy (Abraxane [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for treating adults with unresectable locally advanced or metastatic triple-negative breast cancer in people whose tumors express PD-L1. Approval was based on data showing favorable
Drugs
FDA has accepted for priority review a Sanofi supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps. Patients with the condition often experience recurrence despite previous treatment with surgery or systemic corticosteroids, the company says. The agency
Drugs
Genentech has submitted a supplemental NDA for Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) in people with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions. FDA is reviewing the application under the Real-Time Oncology Review pilot program, which aims to explore a more efficient review process
Drugs
FDA has issued an updated draft guidance, Nonproprietary Naming of Biological Products, indicating that the agency no longer intends to modify the proper names of biological products that have already been licensed or approved under the Public Health Service Act without an FDA-designated suffix in their proper names. The
Drugs
FDA has accepted for review a Foamix Pharmaceuticals NDA for FMX101 (minocycline foam, 4%) for treating inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients aged nine years and older. The agency has set a user fee review action target of 10/20. The submission is supported
FDA Policy/General
Federal Register notice: FDA has announced a 4/8 Pediatric Advisory Committee meeting to discuss drug development for testosterone replacement therapy in male adolescents for conditions associated with a deficiency or absence of endogenous testosterone resulting from structural or genetic etiologies (“classic hypogonadism”). The following topics will be considered for
Devices
A lengthy Kaiser Health News investigative report says FDA is allowing medical device manufacturers to submit summary adverse event reports to databases that are kept from public view, hindering doctors and researchers who are trying to stay aware of issues with the devices. The report details issues with surgical staplers
Devices
The Medical Imaging and Technology Alliance (MITA) says it supports development of a regulatory system that both ensures the safety and efficacy of medical devices and reflects the real-world needs of the innovators and organizations bringing the technologies to market. Commenting on the FDA software precertification pilot program, MITA
Devices
FDA has granted Paige.AI, a start-up company that says it is developing computational pathology focused on artificial intelligence (AI) to transform clinical diagnosis and cancer treatment, a breakthrough device designation. “Paige.AI is focused on providing artificial intelligence tools to pathologists that will enable them to become faster
Drugs
The Medical Device Information Consortium (MDIC) has released a landscape analysis report created from work conducted by its somatic reference sample (SRS) initiative. The report says the subgroup was charged with conducting a thorough analysis of projects related to NGS (next-generation sequencing) reference samples to (1) avoid duplicative efforts;
Drugs
Attorney Eric Alexander (Reed Smith) says that until the Supreme Court decides the Fosamax decision from a New Jersey federal court that were overturned by the 3rd Circuit Court of Appeals, other jurisdictions will continue to look at the same types of questions. In an online blog post, Alexander says
Drugs
FDA has released the FDA-483 with eight observations from a 12/10-12/21/18 inspection at Brookfield Medical/Surgical Supply, a Brookfield, CT, outsourcing facility. The inspection observations were: * · failing to have written procedures for production and process controls designed to assure that the drug products have the
Drugs
FDA has accepted two Allergan supplemental BLAs to expand its Botox (onabotulinumtoxin A) label for treating pediatric patients (two years of age and older) with upper and lower limb spasticity. The pediatric upper limb spasticity indication submission has been designated a six-month priority review with a user fee action
Drugs
Allergan says topline results from three pivotal studies of its rapastinel as an adjunctive treatment of major depressive disorder failed to differentiate from placebo on primary and key secondary endpoints. A company statement says that in all three studies, the drug was well tolerated without any signal of psychotomimetic side
Drugs
FDA has accepted for review a Genentech supplemental NDA for Xofluza (baloxavir marboxil) as a single-dose, oral treatment for people at high risk of complications from the flu. FDA approved the therapy 10/2018 for treating acute, uncomplicated influenza in people 12 years of age or older. The agency
Devices
FDA has updated a 1/18 safety alert that warned health professionals about Zoll Medical’s Zoll LifeVest 4000 Wearable Cardioverter Defibrillator due to concerns that it may fail to deliver treatment if it is not replaced soon after displaying a “call for service” message code 102. Failure to contact
FDA Policy/General
Federal Register notice: FDA is seeking comments on its announced intention to exempt certain flow cytometer instruments from premarket notification requirements, subject to conditions and limitations. The agency has determined that these devices no longer require premarket notification to provide reasonable assurance of safety and effectiveness. All other Class 2
Drugs
University researchers who analyzed 20 new molecular entities (NMEs) approved by FDA between 1/2011 and 9/2017 exclusively on non-inferiority pivotal trials say that both drug sponsors and FDA can do a better job of communicating non-efficacy benefits. In a JAMA Internal Medicine Research Letter, the authors
Devices
FDA has cleared a CurvaFix 510(k) for the CurvaFix Intramedullary Rodscrew for use in pelvic trauma surgery. The rodscrew is a flexible device that is implanted through a small skin incision into the intramedullary space (center of the bone) and then converted into a rigid state to stabilize and
Devices
FDA has cleared an Instrumentation Laboratory 510(k) for the GEM Premier ChemSTAT in vitro diagnostic (IVD) analyzer with Intelligent Quality Management. The device is designed for rapid basic metabolic panel testing at the point of care. The company says it provides laboratory-quality results in less than 70 seconds,