Devices
Elekta Instrument is recalling its Disposable Biopsy Needles from one batch (837838839) because they possibly contain some microscopic stainless steel debris on the inside of the biopsy needle. “If debris on the inside of the biopsy needle comes loose, it may appear in the biopsy sample and delay or make
Drugs
FDA has approved Pfizer’s Beqvez (fidanacogene elaparvovec-dzkt), a gene therapy for treating adults with moderate to severe hemophilia B who currently use factor IX (FIX) prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes. “Beqvez is a one-time treatment
Drugs
FDA has granted fast track designation for Compass Therapeutics’ CTX-009 in combination with paclitaxel in a Phase 2 study to treat patients with metastatic or locally advanced biliary tract tumors that have been previously treated. The company says CTX-009 is a bispecific antibody that simultaneously blocks Delta-like
Drugs
FDA has published a draft guidance, Cancer Clinical Trial Eligibility Criteria: Washout Period and Concomitant Medicines, part of a series of guidances with recommendations about eligibility criteria for clinical trials of investigational drugs or biologics regulated by CDER or CBER to treat cancer. This document specifically has recommendations about the
FDA Policy/General
Federal Register notice: FDA is announcing that OMB has approved an information collection entitled “Electronic Records: Electronic Signatures.” OMB has assigned the collection with the control number 0910-0303, and its approval expires 3/31/2027. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a revised draft guidance entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers.” It is being revised to address questions that manufacturers, packers, distributors, and their representatives (firms) may have when developing
Devices
A 4/2 Warning Letter to Agena Bioscience saying the firm’s iPLEX HS Colon Panel is misbranded and adulterated because it is labeled for research use only (RUO) but reportedly is promoted for human clinical purposes signals a tightening of FDA’s enforcement of RUO labels. That’s the
Drugs
Fresenius Medical Care is recalling (Class 1) its Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapters to correct the instructions for use on the devices after non-dioxin-like (NDL) polychlorinated biphenyl acid (PCBA) leaching was found in their peroxide-cross linked silicone tubing. “These NDL-PCBA
Drugs
FDA has published a draft guidance, Cancer Trial Eligibility Criteria: Performance Status, with recommendations for expanding eligibility criteria to include patients with a wide range of performance status in clinical trials of investigational cancer drugs regulated by CDER and CBER. The document is one in a series of guidances with
Drugs
FDA has published a draft guidance, Cancer Clinical Trial Eligibility Criteria: Laboratory Values, with recommendations for selecting appropriate laboratory values as trial eligibility criteria to avoid unjustified exclusions of diverse trial participants. The document is one in a series of guidances that have recommendations about eligibility for clinical trials of
Devices
A 12/11-12/20/2023 FDA inspection at the Cardinal Health facility in Waukegan, IL, found violations in the firm’s work as an importer/own label distributor of two types of Monoject syringes. A 4/24 Warning Letter says the syringes included in convenience kits marketed by the
Devices
InfuTronix has recalled (Class 1) its Nimbus infusion pump systems due to multiple potential failure modes that may include battery failure, upstream blockage (occlusion), system errors, drug product leakage, high or low flow rate, or damaged housing. According to a recall notice, the devices will not be available or supported
Devices
FDA has cleared an Expanse ICE 510(k) for the ICE Aspiration System for use in peripheral thrombectomy procedures. “The unique dual-lumen design creates the patented Surge Aspiration technology, a novel type of cyclic aspiration at the distal end of the catheter,” the company says. Expanse says the device
Biologics
FDA has accepted for priority review a GSK supplemental BLA for Jemperli (dostarlimab) for combination use with standard-of-care chemotherapy (carboplatin and paclitaxel) to expand treatment to all adult patients with primary advanced or recurrent endometrial cancer, including those with mismatch repair proficient/microsatellite stable tumors. Currently, the drug
Drugs
Dr. Reddy’s Laboratories is recalling six lots of sapropterin dihydrochloride powder for oral solution 100 mg due to powder discoloration in some packets that has led to decreased potency. The issue was discovered during an accelerated stability test in addition to customer complaints, a recall notice says. The drug
Drugs
FDA has approved Utility Therapeutics’ Pivya (pivmecillinam) tablets to treat female adults with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus. An agency announcement says Pivya’s efficacy for its indication was assessed in three trials comparing different dosing regimens to placebo,
Drugs
Boehringer Ingelheim says an FDA draft guidance on key information and facilitating understanding in informed consent could better emphasize the use of plain language with more specific examples and techniques to ensure understanding across diverse patient populations. The company’s comment letter also calls for: * highlighting more prominently the use
FDA Policy/General
FDA has published a draft guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products — Questions and Answers, to address questions firms may have when developing FDA-regulated promotional labeling and ads for specified prescription biological products. The document replaces a 2/2020
Drugs
Healthy Women, an educational resource for women ages 35-64, is calling on FDA to revise the labeling for all fenofibrate drugs to “remedy the widespread misimpression among healthcare professionals that fenofibrates, when used alone or in combination with statins, reduce cardiovascular risk, and the resulting pervasive, improper use of
Drugs
FDA has approved an Amneal Pharmaceuticals ANDA for a generic over-the-counter naloxone hydrochloride nasal spray, 4mg, (generic Narcan) for treating a drug overdose from opioids, including heroin, fentanyl and prescription opioid medications. The nasal spray is designed to rapidly reverse the effects of a life-threatening opioid emergency
Drugs
Sen. Bernie Sanders (I-VT), chairman of the Senate HELP Committee, says the committee is calling on Novo Nordisk to significantly reduce the cost of its Ozempic (semaglutide) and Wegovy (semaglutide) in the United States. He says the committee has opened an investigation into the “outrageously high prices that Novo
Devices
FDA has cleared a Curio Digital Therapeutics 510(k) for its MamaLift Plus, a prescription digital therapeutic for treating postpartum depression. The device is intended for use in patients 22 years of age and older, and as an adjunct to clinician‐managed outpatient care. It treats mild to moderate postpartum