Devices
A 7/24-7/27/2023 FDA inspection at Deymed Diagnostic in Nachod CZ, Czechia, found Quality System Regulation violations in the firm’s production of a variety of Class 2 non-sterile products. A just-released 11/7/2023 Warning Letter said the violations were: * failing to establish and
Drugs
A 7/31-8/4/2023 FDA inspection at the Prime Lab drug manufacturing facility in Ponce, Puerto Rico, found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished drugs. A 1/2 Warning Letter says the specific violations were: * failing to test samples of each component for
Drugs
Englewood, CO-based Leiters Health has recalled 33 lots of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags due to the potential for superpotency. A recall notice says the affected products may contain twice the labeled amount of drug. “The semi-automated IV bag filling equipment used to
FDA Policy/General
Federal Register notice: FDA is announcing that it issued a priority review voucher (pediatric disease product) to Vertex Pharmaceuticals for gaining approval of Casgevy (exagamglogene autotemcel), indicated for treating sickle cell disease in patients 12 years and older with recurrent vaso-occlusive crises. To view the notice, click here.
Devices
FDA has approved Bausch + Lomb’s Teneo Excimer Laser Platform for laser-assisted in situ keratomileusis (LASIK) vision correction surgery for myopia and myopic astigmatism (nearsightedness and nearsightedness with astigmatism). The device features an advanced eye-tracker that operates at more than three times the speed of the laser’s
Devices
FDA has approved a Medtronic PMA for its Percept RC Deep Brain Stimulation (DBS) system. The implanted device transmits electrical signals via slender wires to specific brain targets affected by debilitating neurological disorders like Parkinson’s disease, the company says. Medtronic says Percept RC is the smallest and thinnest dual
Drugs
CDER “first-cycle” drug approvals in 2023 shot up to 84% (46 of 55 NDAs) from 76% (28 of 37 NDAs) in 2022, according to a just-released report entitled Advancing Health Through Innovation: New Drug Therapy Approvals 2023. “This high percentage is in part reflective of the extent to
Devices
FDA says it now considers vaporized hydrogen peroxide (VHP) to be an established sterilization method for medical devices. The agency has revised its final guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to reflect VHP’s recognition for sterilization. The
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Expedited Programs for Serious Conditions — Drugs and Biologics.” The collection supports regulations governing the agency’s expedited programs intended to speed the availability of new therapies to patients with serious conditions. To view the notice, click here.
Devices
Megadyne Medical Product, Inc. is recalling its Mega Soft Universal Patient Return Electrodes to update its Instructions for Use and product labeling to restrict use of the device to patients 12 years and older. A recall notice says the company has received 99 reports of patient burn injuries, including third-
Drugs
FDA has granted Cabaletta Bio a fast track designation for CABA-201, an investigational 4-1BB-containing CD19-CAR T cell therapy for treating patients with dermatomyositis to improve disease activity and for treating patients with systemic sclerosis (SSc) to improve associated organ dysfunction. “CABA-201 is designed to deeply
Drugs
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Devices
Endotronix has submitted a PMA for the Cordella Pulmonary Artery (PA) Sensor System, a heart failure patient management platform that is intended to deliver proactive PA pressure data and other important health data for comprehensive heart failure management at home. The transmitted daily health information permits managing clinicians to achieve
Devices
Insulet Corp. has recalled its Omnipod 5 smartphone application and software that is used to control insulin pumps due to an error in the bolus calculator. An FDA recall notice says the calculator is not recording the decimal point if it is the first value entered when changing a bolus
Drugs
FDA has authorized Florida’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The drug importation program is authorized for two years from the date FDA is notified of the first shipment of drugs to be imported from Canada. FDA
Devices
FDA has cleared a Nanowear 510(k) for the company’s SimpleSense, a nanotechnology-enabled wearable and software platform. “As the first non-invasive, cuffless, continuous blood pressure monitor, and diagnostic, SimpleSense-BP provides a transformational tool in clinical diagnostic management of hypertension and is additive to the wearable platform’
Drugs
FDA has approved Novartis’ Radioligand Therapy (RLT) manufacturing facility in Indianapolis, IN, for producing prostate cancer therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan), which has been on the agency’s drug shortage list. The 70,000-square foot site is designed specifically for RLT manufacturing, and joins the company’s
Biologics
Anti-vaxxers and those opting to shun vaccines over safety concerns or religious beliefs are threatening U.S. public health by risking “population immunity” against some vaccine-preventable infectious diseases. Writing in a 1/5 JAMA Viewpoint online article, FDA commissioner Robert Califf and CBER director Peter Marks sound the
Drugs
FDA has issued ModernaTX a five-item Form FDA-483 after a 09/11-21/2023 inspection of the firm’s Norwood, MA, facility documented GMP violations. For example, the FDA-483 says equipment utilized for drug substance manufacturing is not cleaned properly prior to its usage. “Specifically, your firm
Devices
Rep. Gregory Murphy (R-NC), a practicing urologic surgeon and co-chair of the Congressional Doctors Caucus, is asking FDA for information on its approach to artificial intelligence (AI) in medicine and the tools and authorities it may need. In a 1/3 letter to FDA commissioner Robert Califf, Murphy
Devices
ROi CPS of Republic, MO, has recalled its Regard Wound Dressing change kit (Item Number 800026006) due to it containing nonconforming material/component. ROi CPS manufactured and distributed the medical convenience kits with an irrigation solution component that was subsequently recalled by the component manufacturer, according to a recall notice.
FDA Policy/General
Federal Register notice: FDA is making available a draft document entitled “Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance.” The document is mandated by the Consolidated Appropriations Act of 2023, directing the agency to identify best practices for the efficient prioritization, development, issuance, and