Devices
Medtronic has recalled its HeartWare Ventricular Assist Device (HVAD system) because of the possibility for an interruption to occur in the electrical connection between the system’s power source (battery, AC adapter, or DC adapter) and the HVAD controller. An interruption to the electrical connection, which occurs when the power
Drugs
FDA has released a guidance on “Complicated Urinary Tract Infections (cUTIs): Developing Drugs for Treatment.” The document discusses the overall development program and clinical trial designs for drugs to support an indication for treating cUTIs. “We consider the treatment of cUTIs to be an indication distinct from the treatment of
Drugs
FDA has made available a draft guidance entitled “Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.”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 including adolescents in adult trials at various stages of drug development, considerations for dosing and pharmacokinetic evaluations, safety monitoring, and ethical requirements.
FDA Policy/General
Federal Register notice: FDA has made available a draft guide entitled “Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions” that describes relevant information that should be included in complete test reports for non-clinical bench performance testing provided in PMAs, HDEs,
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Assessment of Pressor Effects of Drugs” that provides advice to sponsors on the premarketing assessment of a drug’s effect on blood pressure. To view the notice, click here.
Devices
FDA has cleared a Branchpoint Technologies 510(k) for its Aura ICP Monitoring System, an implantable and wireless intracranial pressure (ICP) sensor that allows mobile ICP monitoring in brain-injured patients. The device enables continuous telemetric monitoring of parenchymal ICP including continuous ICP waveforms, the company says. It notes that
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonization.” The document provides a framework to facilitate the management of post-approval chemistry, manufacturing, and controls changes for new and marketed pharmaceutical drug substances and drug
Drugs
Allergan has recalled one lot of oral contraceptive Taytulla (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physician sample pack, indicated for use by women to prevent pregnancy. Allergan recently received a physician report that indicated four placebo capsules (first four on-therapy days) were
Drugs
FDA is publishing two draft guidances intended to reduce innovator drug companies’ ability to use risk evaluation and mitigation strategy (REMS) programs to block time entry of generic drugs. In a statement (contains links to the guidances), FDA commissioner Scott Gottlieb says REMS can be exploited in two ways. At
Drugs
FDA says it wants to take steps to clarify the information the agency requires to better inform it about the extent of a drug shortage problem. In a statement, FDA commissioner Scott Gottlieb says the agency also is looking at what additional steps can be taken under existing law to
Devices
FDA has approved a MicroVention PMA for the LVIS and LVIS Jr. stents for stent-assisted coil embolization of intracranial aneurysms. The low-profile visualized intraluminal support device features a braided conformable, resheathable and retrievable design that provides high metal coverage and end-to-end device visualization to support the
Drugs
Nektar Therapeutics has submitted an NDA for NKTR-181, an analgesic opioid molecule that the company says exhibits a reduced incidence of specific side effects, such as euphoria, through the targeted alteration of brain-entry kinetics. The submission is supported by clinical data from 15 studies in 2,234 subjects,
Drugs
FDA has made available an International Council for Harmonization draft guidance entitled “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex” that provides examples of how to identify established conditions for drug manufacturing processes. The examples describe the relevant reporting categories for changes to the ranges of the
Drugs
FDA has granted Genea Biocells an orphan drug designation for GBC0905 and its use in treating facioscapulohumeral muscular dystrophy (FSHD). The company says the small molecule agent works by suppressing DUX4 function, the molecular cause of the disease. It says FSHD is one of the most common muscular dystrophies and
Drugs
FDA has issued a draft guidance, Assessment of Pressor Effects of Drugs, to advise sponsors on the premarketing assessment of a drug’s effect on blood pressure. The document is intended to address precision of blood pressure measurements when assessing the effects of a drug in development. It recommends systemic
Drugs
FDA has published an International Conference on Harmonization draft guidance, Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, that “provides a framework to facilitate the management of post-approval CMC changes in a more predictable and efficient manner.” The document also is intended to demonstrate how increased product
Devices
FDA has published a draft guidance, Recommended Content and Format of Test Reports for Complete Non-Clinical Bench Performance Testing in Premarket Submissions, to describe relevant information that the agency wants included in complete test reports for non-clinical bench performance testing provided in a pre-market submission (PMA, HDE,
Devices
FDA has released the FDA-483 issued following a 4/9-4/24 inspection at Zimmer Biomet, Warsaw, IN. The 11 inspection observations were: * failing to adequately establish procedures for corrective and preventive action; * failing to adequately validate according to established procedures a process whose results cannot be fully verified
Devices
FDA has cleared a Neural Analytics 510(k) for its NeuralBot System, a robotic assistance technology which automatically adjusts orientation and position of its ultrasound products under the guidance of a healthcare professional. When used with its previously cleared Lucid M1 Transcranial Doppler Ultrasound System, the device is intended to
Drugs
FDA has expanded the approval of Pfizer’s Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis, the first oral drug approved for chronic use in this indication. Other treatments must be administered through an intravenous infusion or subcutaneous injection, according to an agency release. Expanded approval
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its “Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees.” The document is intended to assist sponsors in determining when a DMC is needed for monitoring a study and how such committees
Drugs
FDA has approved a TherapeuticsMD NDA resubmission for Imvexxy (estradiol vaginal inserts) for treating moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy, due to menopause. FDA 5/2017 rejected an earlier submission, raising concern about a lack of long-term endometrial