Devices
FDA has granted BrainQ’s artificial intelligence (AI)-powered technology for ischemic strokes a breakthrough device designation based on the company’s latest randomized controlled clinical trial results. BrainQ says it is developing the AI-powered electromagnetic field therapy that aims to enhance recovery and reduce disability after neurological damage
FDA Policy/General
A provision in a budget reconciliation bill moving its way through the U.S. House of Representatives would provide FDA with a $500 million boost for Covid-19 activities. On 2/11, the House Energy and Commerce Committee considered portions of the bill, which will next be consolidated with reconciliation
Biologics
Moderna says it discussing with FDA a proposal to increase Covid-19 vaccine doses in each vial from 10 to 15 doses. The move would help increase the vaccination pace in the U.S. “Implementation of any such changes would be expected to be completed in approximately a two- to
Drugs
Ndal Mfg Inc. has recalled one lot of Manukaguard Allercleanse after determining the products were contaminated with yeast. “The use of Allercleanse (manuka honey) nasal spray contaminated with yeasts, in the population most likely to use it (children, adults, and elderly), may result in adverse events that necessitate medical or
Devices
FDA has classified as Class 1 a Boston Scientific recall of its Emblem S-ICD subcutaneous electrode because of an increased risk of fractures at the distal to the proximal sense ring. If the device fractures during use, it could become unable to deliver therapy to slow very fast heartbeats
Devices
FDA has cleared an Access Vascular 510(k) for its HydroMID midline catheter, which is made using the company’s proprietary biomaterial that it says has been shown to reduce thrombus accumulation by up to 97% when compared to standard polyurethane catheters. HydroMID is described as a 4 French, single
Drugs
CDER’s Office of Pharmaceutical Quality (OPQ) says that early this year it will begin using its Knowledge-aided Assessment & Structured Application (KASA) tool for solid oral dosage forms, manufacturing, and biopharmaceutics regulatory assessments. KASA has been under development for years to improve efficiency, effectiveness, and quality assessment consistency
Drugs
The 2020 annual report of the CDER Office of Generic Drugs shows that 948 ANDAs -- 223 or 19% fewer than in 2019 -- were approved or tentatively approved in 2020, including 72 first generic drugs. The report also shows that 187 product-specific guidances were issued for industry and other stakeholders,
Biologics
CBER director Peter Marks says FDA is starting to think about how to resequence vaccines to cope with emerging virus variants. Appearing as a guest on an American Medical Association Webinar, Marks says that for the Pfizer and Moderna mRNA vaccines, it requires only changing a computer program to change
Devices
Only 10% of artificial intelligence (AI) products cleared by FDA for use in breast imaging provided a breakdown of racial demographics of the data used to validate the algorithm’s performance in public summaries filed by manufacturers. A Stat analysis says the remaining 90% only said that they have been
Drugs
A new study (STEP) finds that 35% of those taking Novartis’ semaglutide for treating obesity lost more than one-fifth of their total body weight, according to University College London researchers. “Three quarters (75%) of people who received semaglutide 2.4mg lost more than 10% of their body weight and
FDA Policy/General
Some 94 oncology physicians, researchers, and leaders have signed a 2/11 letter to President Joseph Biden urging the selection of FDA acting commissioner Janet Woodcock to be the agency’s next commissioner. Those signing the letter include some who served on Biden’s Cancer Moonshot Blue Ribbon Panel when
Biologics
FDA has approved a Regeneron Pharmaceuticals BLA for Evkeeza (evinacumab-dgnb) as an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies to treat adult and pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH). Evkeeza works by binding to and blocking the function of
Drugs
CDER Drug Safety Priorities 2020, the sixth annual report detailing the Center’s safety programs and activities, “highlights key safety-related milestones and accomplishments of 2020 and focuses on the programs and initiatives at the core of CDER’s drug safety operations,” the report says. It also looks at the
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