Devices
GE Healthcare has recalled the Carestation 600 Series Anesthesia Systems because there is a potential for a loose cable connection inside the system which may cause the mechanical ventilation to stop operating. If this happens, the system will sound a high priority audio and visual alarm to alert health care
Drugs
FDA is holding a 3/23 public workshop titled “Identification of Concepts and Terminology for Multi-Component Biomarkers.” The workshop will “address the need to identify standardized high-level conceptual terminology, its potential hierarchy, and include specific language to describe the range of multi-component biomarkers and their application to
Drugs
FDA has published a draft guidance, Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed, with recommendations for applicants seeking licensure under section 351(k) of the Public Health Service Act of a proposed biosimilar or interchangeable biosimilar for
FDA Policy/General
Federal Register notice: FDA is seeking comments on proposed research on “Health Care Providers’ Understanding of Opioid Analgesic Abuse Deterrent Formulations (ADF).” FDA says its own research and other evidence suggests considerable variability in health care providers’ knowledge of and attitudes toward prescription opioid products and practices. The study is
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV–I/II).” The document provides recommendations about using serological tests to reduce the risk of HTLV–I/II transmission
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA efforts to advance patient-focused drug development through a guidance and public workshop. The association says it agrees with FDA on the importance of sponsors engaging with the agency early to discuss clinical outcome assessment development strategy. It recommends
FDA Policy/General
Ropes & Gray says that FDA and the Justice Department “took significant regulatory and judicial action in 2019 that brought attention to alleged compliance gaps across the medical and health product industries, focusing on entities potentially making higher-risk products and on foreign and domestic facilities that may have received
Drugs
Researchers from Harvard Medical School and Northwestern University say their evaluation of hundreds of millions of antibiotic prescriptions dispensed to Medicaid recipients “revealed an alarmingly high proportion of prescriptions that were not infection-related or visit based.” Writing in Health Affairs, the researchers say that identifying the risks associated with
Drugs
FDA has released the FDA-483 issued following a 1/20-1/28 inspection at the Dr. Reddy’s API manufacturing facility in Srikakulam District, Andhra Pradesh, India. The five observations on the form were: * failing to adequately perform process validation for manufactured products at the facility; * investigations are inadequate
Devices
FDA has cleared a Life Spine 510(k) for its Steerable Plateau Ti Spinal System. The company says the device allows for controlled delivery to help positioning in the disc’s anterior space. It features a curved design to match patient anatomy and maximize endplate coverage, it says, adding that
Drugs
Former FDA commissioner Scott Gottlieb has joined Illumina’s board of directors. Illumina says it is focused on DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Since leaving FDA 4/2019, Gottlieb has been appointed to the FasterCures advisory board, Pfizer’ board of
Devices
Becton Dickinson (BD) says FDA this week told the company that modifications to the Alaris infusion pump will require a 510(k) filing, and it will sideline sales of the device through the remainder of this fiscal year. The device, which the company says is used on about 70% of
Drugs
Gilead Sciences is working with Chinese health authorities to begin a randomized, controlled study to determine whether the company’s remdesivir can safely and effectively be used to treat the coronavirus (2019-nCoV) outbreak. In a 2/5 Gilead statement, the company says it is also “expediting appropriate laboratory testing
Devices
The Justice Department says former Walter Reed National Military Medical Center prosthetics and orthotics department chief David Laufer has been indicted by a federal grand jury on five counts of making false statements. The indictment alleges that he failed to report financial benefits he received from an unnamed individual and
Devices
FDA has again posted an online notice that Cardinal Health has alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and PreSource Procedure Packs containing those gowns. The notice says the company has sent urgent medical device recall letters for the devices to its
Biologics
FDA has issued a guidance, Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV-I/II), to provide blood collection establishments agency recommendations on the use of serological tests to reduce the risk of transmission of human T-lymphotropic
FDA Policy/General
Federal Register notice: FDA has announced a 3/11 Nonprescription Drugs Advisory Committee meeting. Panel members will review information submitted to the agency in response to an FDA request entitled “Food Handler Antiseptic Drug Products for Over-the-Counter Human Use; Request for Data and Information.” The information reviewed will
Drugs
Federal Register notice: FDA has made available a draft guidance entitled “Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment.” The document is intended to enhance clinical trial data quality and support development of such treatments. It covers eligibility criteria, trial design considerations, and efficacy endpoints for use in clinical
Drugs
A Medscape commentary says that some of the public speakers addressing an FDA advisory committee have had their expenses and time paid for by the drug companies whose products are being considered. The commentary (free membership required) references a study in BMJ Evidence-Based Medicine that makes clear that “individuals
FDA Policy/General
Federal Register notice: FDA has announced a 4/22 public meeting on “Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.” The meeting will seek stakeholder input related to data standards and the electronic submission system’s past performance, future targets, emerging industry needs, and technology initiatives.
Drugs
FDA has released the FDA-483 with five observations from a 1/13-1/17 inspection at the Lupin API manufacturing facility in Andhra, Pradesh, India. The specific observations are: * critical process parameters should be controlled and monitored during process validation studies; * there is a failure to thoroughly review any
Drugs
FDA says consumers should avoid using dietary supplements containing cesium chloride or any other cesium salt due to significant safety risks such as heart toxicity and potential death. The agency says in an online notice that it also is conveying the warning to healthcare professionals. The notice says that multiple