Devices
FDA has cleared an Acuitive Technologies 510(k) for its Citrefix Knotless Suture Anchor System with Citregen material technology, a bioresorbable synthetic polymer. The device is intended to assist tissue attachment to bone during orthopedic surgeries such as fixation of ligaments or tendon graft tissue repairs of the shoulder, elbow,
FDA Policy/General
Federal Register notice: FDA has announced a 2/26 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to review and discuss a Janssen Biotech emergency use authorization application for an investigational vaccine to prevent Covid-19. To view the notice, click here.
FDA Policy/General
An analysis of CDER Office of Prescription Drug Promotion (OPDP) enforcement actions in 2020 by Eye on FDA found the same pace as in recent years, what the online publication calls “anemic levels of enforcement.” The post says the six regulatory letters were exclusively aimed at smaller, less experienced companies.
Drugs
FDA has issued Eli Lilly an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for treating mild to moderate Covid-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms) who test positive for Covid and who are at high risk
Drugs
Fresenius Kabi Oncology is pleading guilty to concealing and destroying records before a 2013 FDA plant inspection and has agreed to pay $50 million in fines and forfeitures. The Department of Justice says that a criminal information filed in Nevada federal court charges the company with violating the Federal Food,
Devices
FDA has classified as Class 1 a recall of Smiths Medical Medfusion Syringe Pumps (Models 3500 and 4500) due to the risk of medication delivery errors related to a software error. The devices are intended to deliver blood, blood products, prescribed drugs, and other fluids into a patient’s body
Devices
Three senators are asking FDA to quickly conduct a review of the accuracy of pulse oximeters across racially diverse patients and consumers. A 1/25 letter to FDA acting commissioner Janet Woodcock from Sens. Elizabeth Warren (D-MA), Ron Wyden (D-OR), and Cory Booker (D-NJ) references a recent
Devices
CDRH Office of Surgical and Infection Control Devices biomedical engineer Devashish Shrivistava says FDA has enacted an enforcement policy for bioburden reduction systems using dry heat to support single user reuse of certain filtering facepiece respirators during the Covid-19 public health emergency “to help address the urgent public health
Drugs
FDA has given ERX Pharmaceuticals approval to move to the next level in its Phase 1 study evaluating its ERX1000 leptin sensitizer in treating obesity. The company says ERX1000 “has already demonstrated proof-of-concept in first-in-human studies in obese subjects, having been generally well tolerated at doses
Drugs
Genmab and Seagen have submitted a BLA seeking accelerated approval for tisotumab vedotin, indicated for treating patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin is an investigational antibody-drug conjugate directed to tissue factor, a cell-surface protein expressed on multiple solid
Drugs
An FDA review of a Web site and YouTube channel maintained by Clarke Pharmaceuticals, Webster, TX, found the firm is marketing several unapproved drugs, according to a 2/2 Warning Letter. The letter quotes claims from the firm’s Web site that establish the products are intended for use in
Drugs
FDA has approved Allergan’s Botox for treating detrusor (bladder muscle) overactivity associated with a neurologic condition in pediatric patients aged five years and older who have an inadequate response, or are intolerant, to anticholinergic medications. Allergan says that neurogenic detrusor overactivity occurs when the spinal cord and bladder are
Drugs
A group of Democrats on the House Oversight Committee are urging FDA to remove the in-person dispensing requirement for medical abortion drug mifepristone. Last month, the U.S. Supreme Court in a 6-3 split on ideological lines granted an FDA request to reinstate a federal requirement that women
Devices
FDA has cleared an Ava 510(k) for its wearable Fertility Tracker to aid women in ovulation prediction and facilitating conception. To gain FDA clearance, Ava says it submitted multiple performance tests, including a prospective clinical trial demonstrating that the device accurately predicted the day of ovulation. “Results demonstrated that
Drugs
A 5/10-5/15/20 FDA inspection at Allay Pharmaceuticals, Hialeah, FL, found significant violations of current good manufacturing practice (CGMP) for finished pharmaceuticals. A 1/27 Warning Letter also says an unidentified tablet product is adulterated for failing to conform to compendial standards for strength, quality, or purity.
Biologics
Freeline Therapeutics says it has modified its clinical development plan for its adeno-associated virus vector-mediated gene therapy FLT180a program for Hemophilia B to address FDA feedback related to the characterization and comparability of the investigational drug product used in its Phase 1/2 B-AMAZE trial that was
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Allay Pharmaceuticals, Hialeah, FL (1/27) FDA inspected the firm 5/2020 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish adequate written
Devices
FDA says it is monitoring clinical experience with ventilator splitters (multiplexing ventilator tubing connectors) in situations in which no alternatives for invasive ventilatory support are available. Splitters are intended to divide the gas flow from a single mechanical ventilator to deliver a tidal volume to more than one patient and
Drugs
The American Society of Clinical Oncology and Friends of Cancer Research are recommending ways to further efforts to broaden eligibility criteria in cancer clinical trials. In a statement, the two groups say their goal is to make clinical trials more accessible to patients. The joint recommendations are contained in a
Drugs
FDA says its testing of hand sanitizer manufactured by ShangRao Chunyu Technology Co., Jiangxi, China, which was detained at the border and prevented from entering the U.S., found that the product was labeled to contain 75% of the ethanol active ingredient but contained an average of only 58% ethanol.
Drugs
The House Select Subcommittee on the Coronavirus Crisis says it has uncovered additional evidence of Trump administration political meddling in coronavirus guidance, testing, and treatments. In a statement (contains links to documents and letters), subcommittee chairman James Clyburn (D-SC) says the Trump administration: * pressed FDA commissioner Stephen Hahn to
FDA Policy/General
FDA says it has created a Web page listing clinical field studies that are investigating animal cells, tissues, and cell- and tissue-based products (ACTPs) in veterinary patients. “The Web page provides animal owners, veterinarians, researchers, and the public with information on clinical field studies that are being investigated for