Devices
Cue Health has filed a de novo submission seeking permission to market its Cue RSV Molecular Test for at-home and point-of-care use for detecting respiratory syncytial virus. If granted, the test would be the first of its kind for use in people of all ages, the company
Drugs
FDA has removed a partial clinical hold against Salarius Pharmaceuticals and its Phase 1/2 clinical trial evaluating seclidemstat in patients with Ewing sarcoma, a rare and deadly pediatric bone cancer. Salarius says the hold was lifted following the submission of “safety and clinical information to assure the FDA of
Drugs
Members of the FDA Pulmonary-Allergy Drug Advisory Committee will discuss 5/11 whether the ARS Pharmaceutical development program for its ARS-1 (intranasal epinephrine) is sufficient to support a favorable benefit/risk assessment for an indication for emergency treatment of allergic reactions (Type 1) including anaphylaxis in some adults
Drugs
FDA has lifted a clinical hold against two Immuron trials of Travelan, an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting traveler’s diarrhea. The product is designed to target a digestive tract disorder that is commonly caused by Campylobacter and Enterotoxigenic Escherichia coli (ETEC), according to
Devices
FDA has granted Singlera Genomics a breakthrough device designation for its PDACatch assay, a DNA methylation-based liquid biopsy assay for detecting pancreatic adenocarcinoma in individuals at high risk for the disease. The device is based on Singlera's MethylTitan platform, which “utilizes a proprietary library construction approach and
Drugs
FDA has approved Eyenovia’s Mydcombi (tropicamide and phenylephrine HCl ophthalmic spray) for inducing mydriasis for diagnostic procedures and in situations when short term pupil dilation is needed. The company says the device was designed to improve the efficiency in office-based eye exams, as well as pharmacologic mydriasis applications
Drugs
FDA is holding a 5/11-12 workshop entitled “Fiscal Year 2023 Generic Drug Science and Research Initiatives Public Workshop.” The workshop is intended to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these. Topics that will
Devices
FDA has cleared a Samsung Electronics 510(k) for its Irregular Heart Rhythm Notification (IHRN) feature on its Health Monitor app for Samsung Galaxy watches. “Together with the app’s existing on-demand Electrocardiogram (ECG) function, the IHRN feature proactively monitors heart rhythms suggestive of atrial fibrillation (AFib), right from
Drugs
FDA 5/8 granted Ortho-Clinical Diagnostics two de novo marketing authorizations for its Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack for use with the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack for
FDA Policy/General
FDA commissioner Robert Califf is warning that large language models (LLMs) and their use by industry will require regulation because the agency runs the risk of being “swept up quickly by something that we hardly understand.” ChatGPT and other models are becoming more accessible to the public and their use
Drugs
FDA has posted a “consent decree non-compliance” letter to Sun Pharma outlining inspectional findings at the company’s Mohali (Punjab), India manufacturing facility that led to the agency ordering it to take additional corrective actions to get back into compliance with a 2012 consent decree (see earlier story). Sun
Devices
CDRH has launched a new Web page entitled “Antimicrobial Resistance and Medical Devices” that is intended to explain how antimicrobial susceptibility tests are used to help health care providers identify the correct therapy to treat specific bacterial or fungal infections. The devices are sold for use in clinical laboratories and
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Q9(R1) Quality Risk Management.” The International Council for Harmonization document addresses product availability risks due to manufacturing quality issues, lack of understanding as to what constitutes formality in Quality Risk Management (QRM) work, lack of clarity on risk-
FDA Policy/General
Federal Register notice: FDA has released a list of 15 information collections that have been recently approved by OMB. They are: * Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation B12 Pediatric Device Survey * Electronic Products Requirements * Investigational Device Exemptions * General Drug Labeling Provisions and OTC Monograph Drug
Drugs
FibroGen says a Phase 3 study of its anemia drug roxadustat did not meet its primary efficacy endpoint. The MATTERHORN study involving roxadustat for treating anemia in 140 patients with transfusion-dependent lower risk myelodysplastic syndromes showed the proportion of patients who achieved red blood cell transfusion independence in the
Drugs
FDA has issued San Diego-based Ajinomoto Bio-Pharma Services a three-item Form FDA-483 after inspecting the firm in January and citing GMP deficiencies. For example, the inspection form says the firm’s quality oversight of validation activities is inadequate. It also cited its facility and equipment maintenance
Drugs
A citizen petition from Pharmaceutical Research and Manufacturers of America, Partnership for Safe Medicines, and Council for Affordable Health Coverage asks FDA to not approve a proposal from Colorado’s Department of Health Care Policy & Financing that seeks to import drugs from Canada. The petition says the proposal was
Drugs
FDA reviewers are questioning the reliability of an actual use study that was submitted to support approval of a Laboratoire HRA Pharma NDA seeking a prescription-to-nonprescription switch of its Opill, a norgestrel tablet 0.075 mg oral contraceptive pill. In a briefing document released in advance of a
Drugs
FDA has accepted for review a Glaukos NDA for iDose TR (travoprost intraocular implant) for treating open-angle glaucoma or ocular hypertension. The agency has set a 12/22 user fee review action target date of 12/22. The submission is based on data from two Phase 3 pivotal trials
FDA Policy/General
Federal Register notice: FDA has determined that Bayer’s Levitra (vardenafil HCl) oral tablets (5mg, 10mg and 20mg) were not withdrawn from sale due to safety or effectiveness reasons. The determination allows FDA to continue to approve ANDAs that reference the products as long as they meet relevant legal and
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Decentralized Clinical Trials (DCT) for Drugs, Biological Products, and Devices.” The document describes a DCT as a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. To view
Drugs
Public Citizen says it is strongly urging FDA to reject the sNDA submitted by Otsuka Pharmaceutical Co. and Lundbeck for an expanded indication for Otsuka’s atypical antipsychotic Rexulti (brexpiprazole) to treat agitation associated with Alzheimer’s dementia (AAD). The advocacy group’s 5/3 letter says the drug’s