FDA Policy/General
DEVICES FDA has cleared an InvisionHeart 510(k) for its Invision ECG System that is intended to provide a mobile solution for capturing and managing 12-lead ECGs, including the ability to read and visually compare, confirm, report and store diagnostic-quality electrocardiograms. T FDA has cleared RegenScientific’s Renu
FDA Policy/General
AstraZeneca says that the SOCRATES trial that assessed the efficacy of Brilinta/Brilique (ticagrelor) compared with aspirin in patients with acute ischemic stroke or transient ischemic attack missed its primary endpoint of time to first occurrence of any event from the composite of stroke, heart attack, and death. “Fewer events
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Population Pharmacokinetics (PK)” that is intended to assists sponsors in applying PK during drug development. It provides FDA’s current thinking on the data and model requirements for population PK analyses submitted in NDAs/BLAs. The guidance also provides
Drugs
Altaire Pharmaceuticals has recalled numerous brands of over-the-counter eye drops sold at CVS Health due to sterility concerns. A recall notice says that the concerns involve “the sufficiency of quality assurance controls over critical systems in the manufacturing facility.” FDA has determined that the issues indicate a lack
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy.” The document describes FDA’s current thinking on key design considerations for these trials to help with development of such products for contraception. However, it does not
Drugs
Hamilton Medical has recalled its Hamilton-G5 Ventilators due to the potential for “panel connection lost” error messages to be displayed and resulting in the ventilator to stop working and enter an ambient state. “When the ventilator enters an ambient state, the patient breathes room air unassisted and the ventilator
Devices
FDA has issued a Warning Letter to Abington Memorial Hospital’s institutional review board after a bioresearch monitoring inspection found violations. For example, FDA said the IRB failed to review proposed research at convened meetings at which a majority of members of the IRB are present. The IRB was also
Devices
GE Healthcare has recalled its Giraffe and Panda i-Res Infant Warmers because the bedside panels and latch areas of the warmers can crack or break if the unit is moved using the bedside panels instead of the front or rear maneuvering handle. If an infant comes in contact with
Drugs
FDA has cleared an Icotec 510(k) for the Vader One pedicle screw system for use in both minimally-invasive and open spine surgical procedures. The device, which is made from Icotec’s BlackArmor carbon/PEEK (polyetheretherketone) material, was designed for “secure stabilization and post-operative visualization, which is important
Drugs
Janssen Pharmaceutical Companies has submitted a BLA for Darzalex (daratumumab) that seeks approval of a new subcutaneous formulation for treating certain patients with multiple myeloma. Currently, Darzalex is approved as an intravenous (IV) treatment. The submission is supported by data from the Phase 3 COLUMBA (MMY3012) study that included a
FDA Policy/General
Federal Register notice: FDA has cancelled an 8/8-planned public workshop entitled “Development of Antiviral Drugs for the Treatment of Adenoviral Infection in Immunocompromised Patients.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials.” The document provides institutional review boards, industry, clinical investigators, and FDA staff with factors to consider when evaluating the appropriateness of a live case presentation within a clinical investigation conducted
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process.” The document is intended to assist applicants in revising an existing monograph or developing a new monograph under the United States Pharmacopeial Convention Pending Monograph Process
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Using the Inactive Ingredient Database.” The document provides recommendations for how to use the database when developing drug products. It is intended to give applicants a clearer understanding of the information provided in the database and its terminology. To
Drugs
FDA has published a draft guidance, Population Pharmacokinetics, to assist NDA and BLA sponsors to apply population pharmacokinetic (population PK) analysis. The document says population PK is frequently used to guide drug development and inform recommendations on therapeutic individualization, such as through tailored dosing. “Adequate population PK data collection and
Drugs
FDA has issued a draft guidance, Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy, with recommendations for clinical trials designed to establish clinical effectiveness and safety for hormonal drug products intended to prevent pregnancy. The document says that drug product development in hormonal contraception has evolved
Biologics
Omeros and FDA have reached agreement on a response-based primary endpoint for its pivotal trial to support a BLA for narsoplimab to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Narsoplimab is described by the company as a human monoclonal antibody targeting mannan-binding lectin-associated serine
Drugs
FDA has accepted for review a Neurocrine Biosciences NDA for opicapone, a once-daily, oral, selective catechol-O-methyltransferase inhibitor as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing off episodes. The agency has set a standard 12-month review with a user fee target
Drugs
The Virginia U.S. Attorney says Reckitt Benckiser has agreed to pay $1.4 billion to resolve potential civil and criminal liability relating to marketing of its opioid addiction treatment drug Suboxone. A news release says the resolution is the largest recovery by the federal government in an opioid drug
Devices
FDA scientists have developed and qualified under its Medical Device Development Tools (MDDT) program a “Tissue Mimicking Material (TMM) for Preclinical Acoustic Performance Characterization Of High Intensity Therapeutic Ultrasound (HITU) Devices. ” HITU developers can use the qualified tool to test device safety and effects in a preclinical setting using “phantoms”
Drugs
FDA says it has completed “capability assessments” of the 28 European Union (EU) member states under the FDA/EU Mutual Recognition Agreement (MRA). The completed assessments allow FDA to rely on the drug inspections conducted by these foreign regulatory authorities. The 28 regulatory authorities found to be capable are those
Devices
A Pennsylvania federal court has asked the 3rd Circuit Court of Appeals to answer whether the state recognizes a strict liability claim for a manufacturing defect of a prescription medical device. A Washington Legal Foundation (WLF) Legal Pulse online post says the Pennsylvania case is similar to one pending in