Devices
The CBER Office of Compliance and Biologics Quality says a Tiger Medical Web site is selling and distributing the Alere Determine HIV-1/2 Ag/Ab combo test kit without imposing the restrictions that are part of the kit’s approval. A 5/29 untitled letter says the agency’s
Drugs
FDA has released the FDA-483 with five observations issued following a 5/14-5/24 inspection at Glenmark Pharmaceuticals, a Madhya Pradesh, India, finished oral solid dose manufacturer. The specific observations were: * failing to establish and document the accuracy, specificity, and reproducibility of test methods; * failing to have laboratory
Drugs
FDA has approved a Partner Therapeutics NDA for leukine for treating adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome). The company notes that efficacy studies of Leukine could not be conducted in humans with acute radiation syndrome for ethical and feasibility
Drugs
FDA has accepted an Amag Pharmaceuticals NDA for bremelanotide, a first-in-class melanocortin 4 receptor agonist for treating hypoactive sexual desire disorder (HSDD) in premenopausal women. The user fee review action target date is 3/23/2019. HSDD is the most common type of female sexual dysfunction, affecting about
Devices
FDA has cleared a Rodo Medical 510(k) for the Rodo Smilekey, an induction remover device for use with the Rodo Abutment System. The device uses Rodo’s proprietary induction technology to remove dental prostheses retained by the Rodo Smileloc in less than 10 seconds without occlusal holes or damaging
Drugs
The CDER Office of Generic Drugs says the 843 fully approved and 184 tentatively approved generic drug applications in 2017 had an estimated cost-savings of $8.8 billion through 12/2017 and $11.8 billion through 2/2018. A cost savings report says the agency approved the most generic
Drugs
A 9/25-9/28 FDA inspection at Kolmar Korea Co., Sejong-si, South Korea, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a 5/18 Warning Letter. Specific violations listed in the letter are: * failing to thoroughly investigate any unexplained discrepancy or failure
Drugs
FDA has warned nine online networks that operate a total of 53 Web sites to stop illegally marketing potentially dangerous unapproved and misbranded versions of opioid medications, including tramadol and oxycodone. An agency news release says that Warning Letters went to these networks: AnonShop. Eassybuyonline, Instabill ECS-Rx, Medstore.biz,
Drugs
A 12/4-12/8/17 FDA inspection at IDT Australia, Boronia, Victoria, Australia, found current good manufacturing practice (CGMP) regulations deviations in the firm’s manufacturing of active pharmaceutical ingredients (API) and violations in its manufacturing of finished pharmaceuticals. A 5/23 Warning Letter says the API deviations were:
Drugs
FDA has accepted for priority review a Genentech supplemental BLA for Hemlibra (emicizumab-kxwh) for adults and children with hemophilia A without factor VIII inhibitors. The submission is based on data from the Phase 3 HAVEN 3 study. In the study, adults and adolescents with hemophilia A without factor VIII
Drugs
FDA has approved Eli Lilly’s Alimta (pemetrexed for injection) in combination with carboplatin and Merck’s Keytruda (pembrolizumab) for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer, irrespective of PD-L1 expression status. Previously, the combination use was permitted under an accelerated approval. The
Drugs
FDA says it is committed to using a multi-component system of pharmacovigilance to be able to intervene proactively and effectively in anticipation of changes in drug abuse. Writing in a New England Journal of Medicine Perspective column, three agency senior executives describe pharmacovigilance steps taken involving gabapentinoids, the botanical
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Fertility Partnership St Peters, MO (5/24): FDA inspected the firm in March and cited deviations from the regulations governing human cells, tissues, and cellular and tissue-based products
Devices
FDA has completed its review of the agency-required Medifocus post-approval study of its Prolieve Thermodilation system. The company says the study involved 225 symptomatic benign prostatic hyperplasia (BPH) patients. The 12-year study with five-year follow-up data confirms long-term safety, efficacy, and durability of the
Devices
FDA has cleared an EOS Imaging 510(k) for its hipEOS 3.0 surgical planning software. The surgical planning software for total hip arthroplasty is part of the company’s EOSapps suite of online 3D surgical planning solutions (spineEOS, hipEOS, kneeEOS). The hipEOS 3.0 is intended to simulate the
Devices
FDA has cleared a Royal Philips 510(k) for the Ingenia Elition 3.0T magnetic resonance (MR) device and two clinical applications, Philips Compressed SENSE and 3D APT. The device and apps provide faster exam times and improved analytics to allow automatic planning, scanning and exam processing, the company says.
Drugs
FDA commissioner Scott Gottlieb says the agency is taking steps to make the entire continuum of drug development more efficient as a way to lower costs and expand opportunities for innovation. Speaking 6/2 at the annual meeting of the American Society of Clinical Oncology, Gottlieb outlined steps being taken
FDA Policy/General
An FDA 5/23 Warning Letter to Creative Science Inc., Ballwin, MO, says the company’s P-Bloc product is a new animal drug that is not generally recognized among experts as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. Further, the letter
Devices
FDA has cleared a Spineology 510(k) for its Rampart One Standard ALIF interbody fusion system for use with or without supplemental fixation. The system includes both standard and oblique interbody devices, each with integrated fixation screws. The device is designed to minimize vascular retraction and exposure, the company says.
Drugs
FDA has approved Mylan’s Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Amgen’s Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with
FDA Policy/General
Federal Register notice: FDA has issued a proposed order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection from postamendments Class 3 (premarket approval) devices into Class 2 (special controls), subject to premarket notification. The devices are intended
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.” The document focuses on appropriate criteria for inclusion in adult trials at various stages of drug development, considerations for dosing and pharmacokinetic evaluations, safety monitoring, and ethical