Drugs
An April inspection of Taenaka Kogyo (Mobara, Chiba, Japan) has resulted in a four-observation Form FDA-483 that cites significant GMP violations. For example, the agency says the firm’s training was not regularly conducted by qualified individuals, and it did not cover the operations the employees performed. The
Biologics
FDA has posted a Form FDA-483 issued to Biocon Biologics at the end of a July inspection of the firm’s Bengaluru, India manufacturing facility. The document cites 10 observations: 1. Procedures designed to prevent microbiological contamination of drug products did not include adequate validation of the aseptic process.
Devices
FDA has published a draft guidance, Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle, with recommendations on how voluntary patient preference information (PPI) may be considered by FDA staff in medical device decision-making. The document’s objectives are to: * encourage submission of PPI, if available, by
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection reinstatement entitled “Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation (CERSI) B12 Pediatric Device Survey.” The collection supports a planned survey of industry and other key stakeholders in the medical device ecosystem to identify the barriers
Devices
Abbott Diabetes Care is recalling (Class 1) three lots of its FreeStyle Libre 3 sensors after finding that a small number of them may provide incorrect high glucose readings, which if undetected may pose a potential health risk for people living with diabetes. The sensors are used in Abbott’s
Devices
FDA says a July Medtronic recall of some Medtronic McGrath MAC Video Laryngoscopes to remove them from where they are used or sold is Class 1. The company also issued a recall updating instructions for using other models of the devices without removing them. An agency notice says the recalls
Drugs
The Department of Justice says Glenmark Pharmaceuticals, a generic drug manufacturer based in Mahwah, NJ, has agreed to pay $25 million, based on its ability to pay, to resolve its alleged liability under the False Claims Act for conspiring to fix the price of generic pravastatin (Pravachol). A department statement
Devices
Breas Medical is recalling (Class 1) its Vivo 45 LS ventilators to update the use instructions after internal testing of the devices identified the potential for a short-term increase in formaldehyde exposure for people using new ventilators for the first time. “The use of affected product and short-term
Drugs
Eli Lilly says data from its QWINT-1 and QWINT-3 Phase 3 clinical trials evaluating once-weekly insulin efsitora alfa in adults with Type 2 diabetes showed non-inferiority A1C reduction compared to the most frequently used daily basal insulins. The trials evaluated the therapy in patients using basal
Drugs
An Associated Press analysis of FDA records shows that agency inspectors have not returned to some 2,000 drug manufacturing firms to conduct surveillance inspections since before the 2019 Covid-19 pandemic. An AP report says the firms that are overdue for inspections represent about 42% of the 4,700
Drugs
The FDA Antimicrobial Drugs Advisory Committee will consider 9/9 a resubmitted Iterum Therapeutics NDA for sulopenem etzadroxil/probenecid, an oral treatment for uncomplicated urinary tract infections caused by designated susceptible bacteria in adult women. An agency briefing document released in advance of the meeting says the committee is to
Drugs
Biosimilars advocacy group Biosimilars Forum is asking FDA for further information and clarification on certain areas of the agency’s recent draft guidance entitled “Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products and Combination Products.” Regarding the scope of the guidance, Biosimilars Forum says in just-
Drugs
FDA has published a guidance, Control of Nitrosamine Impurities in Human Drugs, to recommend steps that manufacturers and applicants of active pharmaceutical ingredients (APIs) and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in drug products. The document also describes conditions that may introduce nitrosamine
Devices
Baxter is recalling (Class 1) certain Volara Single Patient Use Circuits and Blue Ventilator Adapter Assemblies due to reports that the components’ handset plugs may disconnect from the nebulizer port. “When using the Volara system in line with a ventilator and without a nebulizer connected to the blue ventilator adapter,
FDA Policy/General
Federal Register notice: FDA has determined that Pfizer’s Flagyl (metronidazole) tablets, 250mg and 500mg, were not withdrawn due to safety or effectiveness reasons. The determination permits the agency to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. The product is indicated
Drugs
The Association for Accessible Medicines (AAM) says it recognizes that the International Council for Harmonization M14 draft guidance on general principles on plan, design, and analysis of pharmacoepidemiological studies that use real-world data for safety assessment of medicines “includes recommendations and high-level best practices for the conduct of
Devices
In a new motion, the American Clinical Laboratory Association, HealthTrackRx Indiana, and HealthTrackRx, Inc., are asking a Texas federal court to grant summary judgment in favor of their 5/29 suit against FDA and vacate the FDA 5/4 final rule asserting oversight over laboratory-developed tests. In their latest
Drugs
FDA says its review of a Web site maintained by SoloVital in Chula Vista, CA, found that the company markets Umary Hyaluronic Acid, an unapproved new drug, in the U.S. An 8/27 Warning Letter says an FDA analysis determined that a sample of the company’s Umary contains
Drugs
The Department of Justice says Paul Lamberty of Folsom, CA, pleaded guilty in a Massachusetts federal court to one count of conspiracy to defraud the United States and one count of the introduction of misbranded drugs with the intent to defraud and mislead. A department statement says Lamberty operated Web
Drugs
Vanda Pharmaceuticals has filed a lawsuit against FDA seeking an advisory committee meeting to assess the company’s pending NDA for tradipitant and its use in treating symptoms of gastroparesis in adults. Gastroparesis is a rare condition characterized by delayed gastric emptying that results in nausea, vomiting, bloating, fullness after
Devices
FDA has cleared a Zynex 510(k) for its TensWave device for managing pain. The transcutaneous electrical nerve stimulation therapy is intended for use in reducing chronic and acute pain, according to the company. It says the device offers a user-friendly, portable design that can be easily integrated into
Devices
FDA has cleared a Ventis Medical 510(k) for the VM-2000, an emergency transport ventilator that allows medical personnel to provide respiratory support with robust volume and pressure control modes in the field. The company says the battery-operated device weighs less than many standard laptop computers. It features