Devices
A 7/19-8/5/21 FDA inspection at DSAART, doing business as Alpha Aesthetics, Carson City, NV, found violations of Quality System and Medical Device Reporting regulations in the firm’s manufacturing of silicone facial and body contouring implants. A recently-released 11/24/21 Warning Letter says the
Biologics
FDA has published a draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, with recommendations for sponsors, investigators, and other interested parties on the use of digital health technologies for remote data acquisition from participants in clinical investigations evaluating medical products. The document defines a digital health
Drugs
University of Minnesota researchers have submitted an emergency use authorization application for fluvoxamine (Luvox and others), a generic antidepressant that they believe could be used as a Covid-19 treatment. MedPage Today reports that the researchers have been investigating fluvoxamine and other repurposed drugs. They said they prepared the application
Drugs
FDA has placed a clinical hold on 10 Gilead trials studying injectable versions of its experimental HIV treatment lenacapavir. Endpoints News reports that the agency expressed concerns that vials made of borosilicate glass could lead to the formation of sub-visible glass particles in the solution. Gilead CEO Merdad Parsey
FDA Policy/General
FDA Webview is posting the following Federal Register notices that published during our annual holiday break. 12/30/2021 Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. They are: * Medical Device User Fee Cover Sheet and Device Facility User Fee Cover
Devices
A 7/15-7/30 FDA inspection at Global Medical Production, Jiaxing, China, determined that its sterile and non-sterile electrosurgical scissors, sterile electrosurgical graspers, and sterile veress pneumoperitoneum needles are adulterated due to Quality System Regulation violations. A recently-released 11/16 Warning Letter says specific violations were: * failing
Drugs
FDA says its laboratory testing of Impacta Health Hand Sanitizer manufactured by Guangzhou Shiruoni Cosmetics Co., Guangzhou, Guangdong, China, determined that it was adulterated and misbranded. A 12/7 Warning Letter says the hand sanitizer is adulterated due to violations of Current Good Manufacturing Practice (CGMP) requirements and misbranded because
Drugs
Janssen has submitted its bispecific teclistamab to FDA seeking an indication to treat patients with relapsed or refractory multiple myeloma. (Bispecific agents are able to bind to two antigens at the same time.) Fierce Biotech reports that Phase 1 studies showed a solid response rate in heavily treated patients. Last
Drugs
IMC Wash-Free Hand Sanitizer, declared to be manufactured by Guangdong Kemei Pharmaceutical Technology Co., Shishan Foshan, China, is an unapproved new drug that is adulterated and misbranded, according to a 12/14 FDA Warning Letter. The letter says the sanitizer is adulterated because it is labeled to contain 75%
Devices
FDA has published a draft guidance, Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology, highlighting technical considerations for the development of medical devices employing physiologic closed-loop control technology to ensure safe and effective use. The document also provides recommendations for the content of premarket submissions — 510(
Devices
A 6/7/21-7/7/21 FDA inspection at the Medtronic facility in Northridge, CA, found Quality System Regulation and Medical Device Reporting violations in the firm’s work manufacturing the MiniMed 600 series insulin infusion pumps and software and remote controllers used with the Paradigm and MiniMed series
Devices
FDA has published a draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions, to provide a risk-based framework that can be used in the credibility assessment of computational modeling and simulation (CM&S) used in medical device regulatory submissions. The document defines credibility
Drugs
FDA has issued an emergency use authorization (EUA) for Merck’s molnupiravir for treating mild-to-moderate coronavirus disease in adults with positive results of direct SARS CoV-2 viral testing who are at high risk for progressing to severe Covid-19, including hospitalization or death, and for whom alternative
Drugs
Citing a possible defective delivery system, Padagis US has recalled three lots of nitroglycerin lingual spray in 12 g spray bottles. The company says “there is a remote risk that the product may not properly dispense medication to patients in the event of a malfunction of their dispensing unit.” The
Drugs
FDA issued a 12/22/21 emergency use authorization for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for treating mild-to-moderate Covid-19 in adults and children age 12 and older with positive results of direct SARS-CoV-2 testing who are at
Drugs
FDA has tentatively approved an Amphastar ANDA for vasopressin injection, 20 units/mL, 1 mL single-dose vial, indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. BioSpace reports that the agency determined that the Amphastar product is bioequivalent and therapeutically equivalent
Drugs
FDA has accepted an Amylyx Pharmaceuticals NDA for its AMX0035, an experimental therapy to address pathways leading to neuronal cell death in Alzheimer’s patients. The agency set a 6/26 PDUFA target date to act on the NDA, reports MedCity News. The agency granted the NDA priority review and
Devices
FDA has given 510(k) clearance to the Bioventus neXus bone scalpel access handpiece. The company says the device is a handheld tool designed for resection, shaving, and removal of soft tissue and bone during minimally invasive surgery. Bioventus says it will launch the neXus scalpel this year.
Devices
FDA has published a guidance, Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH), to identify the key features of non-clinical and clinical investigation plans used to support IDE applications, PMAs, de novo classification requests, and some 510(k) submissions for devices
Drugs
FDA has granted fast track designation for Celularity’s CYNK-001, described as a novel on-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer cell therapy for treating patients with acute myeloid leukemia. The company says CYNK-001 previously received orphan drug designation for malignant gliomas and
Drugs
FDA has approved Novartis’ Cosentyx (secukinumab) to treat active psoriatic arthritis in patients age 2 and older and for active enthesitis-related arthritis in those age 4 and older. The company says Cosentyx is the first biologic indicated for enthesitis-related arthritis and the only biologic agent approved for both
Drugs
FDA has granted a fast track designation to lecanemab, BioArctic AB and Eisai’s investigational anti-amyloid beta protofibril antibody to treat early Alzheimer’s disease. The drug was granted breakthrough therapy designation in 6/2021. Eisai started a rolling BLA submission for lecanemab under the accelerated approval pathway in