Drugs
FDA says five drug firms will need to recall their metformin for diabetes drug products after sampling detected the impurity N-Nitrosodimethylamine (NDMA) above the agency’s acceptable intake limit (see earlier story). The agency contacted the firms and their recall notices will be posted accordingly on FDA’s Web
Drugs
FDA has issued a draft guidance, Orange Book Questions and Answers to help interested parties use the Orange Book. The document gives answers to commonly asked questions received from parties such as prospective drug product applicants, drug product applicants, and approved application holders. The Orange Book identifies drug products approved
Drugs
An FDA letter to healthcare facilities is reminding staff to use the correct decontamination cycle associated with certain models of the Advanced Sterilization Products Sterrad Sterilization Systems and to only decontaminate compatible N95 or N95-equivalent respirators for reuse during the Covid-19 pandemic. The letter says that the sterilization
Drugs
FDA says it has established a docket to obtain information and comments from patients, patient advocates, the scientific community, health professionals, other regulatory and health authorities in the global community, regulated industry, and the general public on steps and successful approaches to establishng a rare disease clinical trial network. A
Drugs
In a move to increase access to naloxone, perhaps even through regulatory approval of over-the-counter sales, CDER staff developed a model drug facts label for such sales to determine whether consumers understood the key statements for safe and effective use. Writing in a New England Journal of Medicine
Drugs
The Food and Drug Law Institute (FDLI) says over-the-counter drug monograph reforms included in the Coronavirus Aid, Relief, and Economic Security (CARES) Act give FDA additional resources and make the monograph system more nimble, transparent, certain, and conducive to innovation. In an online article, FDLI says the added
FDA Policy/General
Federal Register notice: FDA has made available a revised guidance entitled “Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised).” The revision reflects a 5/8 court order that postponed the final rule entitled “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements.” To view the notice, click here.
Drugs
FDA has issued an immediately-in-effect guidance, Effects of the Covid-19 Public Health Emergency on Formal Meetings and User Fee Applications—Questions and Answers, to give answers to frequently asked questions about regulatory and policy issues related to drug development for the duration of the HHS public health
Devices
FDA is investigating MicroGenDX, a Texas laboratory that was dropped by a Florida hospital chain due to what it said were delayed and unreliable Covid-19 test results. USA Today reports that AdventHealth, which has 45 hospitals in nine states, terminated its Florida contract with MicroGen DX over questions about
Biologics
Two consumer advocacy groups — Public Citizen and Lower Drug Prices Now — say that Trump administration coronavirus “vaccine czar” Moncef Slaoui should be classified as a special government employee and thus subject to the conflict of interest code and disclosure requirements. A complaint filed with the HHS Inspector General and the
Drugs
FDA has informed MacroGenics that it no longer plans to hold an Oncologic Drugs Advisory Committee meeting to discuss the company’s BLA for its margetuximab as a treatment for HER2-positive metastatic breast cancer. The agency also said it still expects to meet the 12/18 PDUFA goal date
Drugs
As part of its ongoing testing and investigation into high levels of a possible cancer-causing impurity in some marketed drugs, FDA has added diabetes drug metformin to its watch list of drugs with potential safety concerns. The agency says it is notifying companies whose drugs had N-nitrosodimethylamine (NDMA)
Devices
FDA has cleared a Gynesonics 510(k) to market its next generation Sonata System 2.1 for Transcervical Fibroid Ablation. The device integrates an intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device to provide an incision-free, uterus-preserving, transcervical treatment for symptomatic uterine fibroids, according to the
Devices
Medtronic has recalled (Class 1) its HeartWare Ventricular Assist Device (HVAD) Pump Outflow Graft and Outflow Graft Strain Relief because the outflow graft of the pump may tear and the strain relief screw may break during assembly prior to implant but might not be noticed until, during or after the
Devices
FDA has released a reference panel to support its evaluation of diagnostic tests for Covid-19. “Reference panels are an additional step to ensure the quality of the tests, validation of new assays, test calibration, and monitoring of assay performance,” the agency says. “Nucleic acid tests identify infection by confirming
Drugs
Researchers from several academic facilities are proposing a system of “quality scores” to enable health systems and other purchasers and payers of medication to differentiate among drug products according to evidence-based metrics. Writing in a MedRxiv pre-print, the researchers say that currently buyers and payers of pharmaceuticals have
Devices
FDA has posted a list of recent and upcoming enhancements to CDRH’s Electronic Medical Device Reporting (eMDR) system. The post says the eSubmitter client is updated concurrently with eMDR, but AS2 (gateway to gateway connection) submitters should use the information in the post to plan system updates to align
Drugs
FDA has approved Astellas Pharma’s VESIcare LS (solifenacin succinate) oral suspension to treat neurogenic detrusor overactivity (NDO), a form of bladder dysfunction related to neurological impairment, in children age two and older. VESIcare tablets were approved in 2004 to treat overactive bladder in adults age 18 and older. An
Devices
FDA has denied an 11/27/17 petition submitted by S. Albert Edwards, a Lincolnshire, IL, pharmacist, asking that the agency investigate Edwards Lifesciences’ marketing of its Myxo ET Logix 5100 annuloplasty ring between 2007 and 2009 without agency 510(k) clearance or PMA approval. The denial letter says FDA
Drugs
GlaxoSmithKline has submitted additional materials to FDA regarding the company’s 11/1/19 petition about four categories of information concerning the use of Zofran (ondansetron) in pregnancy. The 5/22 GSK letter says that the company is aware that FDA and Novartis, the current Zofran NDA holder, may be
Drugs
FDA has accepted for review a Fresenius Kabi BLA for a pegfilgrastim biosimilar candidate (MSB11455) that references Amgen’s Neulasta, indicated for reducing the incidence of infection associated with febrile neutropenia, a serious side effect of chemotherapy. The drug works by stimulating the body’s own production of white blood
Devices
FDA has denied a 9/6/06 Public Citizen Health Research Group petition asking it to revoke the Cyberonics PMA approval for its Vagus Nerve Stimulation device for managing treatment-resistant depression (TRD). The petition claimed that the device was “ineffective” for TRD and has not demonstrated a reasonable assurance