Biologics
GSK says it will seek FDA approval for an expanded use of Arexvy (respiratory syncytial virus vaccine, adjuvanted) in adults aged 50 to 59, including those at increased risk of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) due to certain underlying medical conditions. The submission will be based
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Standardized Reporting Forms for FDA Federally Funded Public Health Projects.” The collection supports federally funded public health projects administered by the agency, and facilitates the receipt of information related to an awardee’s progress in completing agreed-
Drugs
Three former senior Intarcia Therapeutics employees who were closely involved in the development of the company’s ITCA 650 (exenatide in DUROS device), indicated for improving glycemic control in adults with Type 2 diabetes, say CDER made “erroneous statements” in a “misleading” presentation to the 9/21 meeting of the
Drugs
FDA has published a draft guidance, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities, describing how the agency requests and conducts voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, compounded, or held, and at drug facilities covered under the agency’s bioresearch monitoring program.
Devices
FDA has approved Medinol’s EluNIR-PERL drug-eluting stent for treating coronary artery disease. The next-generation stent features four radiopaque markers, two at each end of the stent, and a hybrid polymer-metal radiopaque catheter tip, according to the company, which provides “outstanding visualization” during PCI procedures and
Devices
FDA has cleared a Denti.AI 510(k) for its Denti.AI Detect, which the company describes as a “state-of-the-art imaging solution” engineered to aid dental professionals in identifying prevalent dental diseases such as caries, periapical lesions, and bone loss from dental x-rays. The clearance was
Drugs
A Florida public broadcasting station says documents filed by state officials in a Florida federal court indicate it is unlikely FDA will meet its previously stated intention to rule by 10/31 on a Florida proposal to import some drugs from Canada for use in government programs such as Medicaid,
Drugs
FDA has accepted for review an Akebia Therapeutics NDA resubmission for vadadustat as a treatment for anemia due to chronic kidney disease in adult patients on dialysis. The agency has classified the submission as a Class 2 response and set a 3/27/2024 review action target date. A 3/
Drugs
BioXcel Therapeutics says an independent third-party audit of data integrity at one TRANQUILITY II Phase 3 trial site of the company’s BXCL501 for the acute treatment of agitation associated with dementia reported positive findings. “The team of auditors did not identify any findings that they believe impact the
Drugs
FDA commissioner Robert Califf posted a positive online post-trip report on his recent official visit to India. He says he made the trip “to strengthen our collective efforts to advance the development and availability of medical products that both our countries and the rest of the world need.” While
Drugs
FDA has published a draft guidance, Topical Dermatologic Corticosteroids: In Vivo Bioequivalence, to assist applicants who submit ANDAs for the products. The document has recommendations for in vivo studies to demonstrate the bioequivalence of topical corticosteroids. When finalized, the draft will replace a 6/1995 guidance, FDA says. It says
Drugs
FDA has released the form FDA-483 issued following a 6/26-7/4 inspection at UCB Farchim SA, a drug substance and bulk drug product manufacturer in Bulle, Fribourg, Switzerland. The four inspection observations were: * quality unit oversight over quality control operations is deficient, including laboratory and production electronic
Drugs
Attorney Dara Katcher Levy (Hyman, Phelps & McNamara) says an FDA 10/23 draft guidance on communications from firms to healthcare providers about scientific information on unapproved uses of approved/cleared medical products represents a shift in the agency’s approach. Writing in her firm’s online FDA Law Blog,
Devices
ResMed Ltd. has recalled (Class 1) its Astral 100 and Astral 150 ventilators due to what FDA calls a “device design” issue. If an affected ventilator is running on its internal battery, which is not intended to serve as a primary power source, the device’s low/critically low battery
Drugs
FDA has accepted for review an AstraZeneca supplemental BLA that seeks approval for a self- or caregiver-administered option for FluMist Quadrivalent, a needle-free nasal spray. The submission is based on data from a usability study that the company says “confirmed that individuals over 18 years of age could
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Export Certificates for FDA Regulated Products.” The collection supports agency regulations that pertain to exporting FDA-regulated products and are intended to ease restrictions on exportation. The provisions also require it to issue written export certifications within
FDA Policy/General
Federal Register notice: FDA is making available a revised draft guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” The document provides the agency’s current thinking on common questions regarding certain communications by
Devices
FDA, Health Canada, and the UK’s Medicines and Healthcare Products Regulatory Agency have published five guiding principles for predetermined change control plans (PCCPs) for machine learning-enabled medical devices (MLMDs). An FDA post says the principles “draw upon the overarching good machine learning practice guiding principles the three agencies
FDA Policy/General
FDA says its review of a Web site maintained by Embryll Life Sciences in Middletown, DE, determined that the firm is marketing Lanomax, an unapproved new animal drug product to treat cataracts in animals. A 10/4 Warning Letter says the product is an adulterated unapproved new animal drug and
Drugs
FDA has cleared an NKGen Biotech IND for its SNK01 NK cell therapy to treat Alzheimer’s disease. The company says SNK01 is an autologous, non-genetically modified NK cell product that has enhanced cytotoxicity and activating receptor expression. An approved trial of 30 patients with moderate Alzheimer’s disease
Drugs
FDA has granted Shanghai-based Zhimeng Biopharma an orphan drug designation for its small-molecule KCNQ2/3 selective opener compound (CB03) for treating amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease). The company says a Phase 1 study evaluating the safety, tolerability, and pharmacokinetics of CB03 in
Devices
FDA has approved a Medtronic PMA for the Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV MRI SureScan defibrillation lead for treating fast heart rhythms that can lead to sudden cardiac arrest. “The Aurora EV-ICD system is the first-of-its-kind to provide the