Devices
CDRH is announcing new steps to improve medical device sterilization. For one, the Center has updated its Recognized Consensus Standards database to include the complete recognition of one sterilization standard (ISO 22441:2022). The new standard, Sterilization of Health Care Products — Low Temperature Vaporized Hydrogen Peroxide — Requirements for the Development,
Drugs
FDA says it is expanding CURE ID, a joint initiative with the National Center for Advancing Translational Sciences/National Institutes of Health, which is an Internet-based repository that allows the global community to report novel uses of existing drugs for difficult-to-treat diseases. In a “Q&A
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk,” and two supplemental documents entitled “M7(R2) Addendum: Application of the Principles of the ICH M7 Guidance to Calculation of Compound-Specific
Drugs
FDA has released the form FDA-483 issued following an 8/1-9/1/22 inspection at Catalent Indiana, a sterile human drug and biologic product manufacturer in Bloomington, IN. The 12 specific inspection observations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any
Drugs
The National Center for Health Research (NCHR) says that while it supports FDA efforts to be flexible and provide a more open application of scientific and regulatory judgment when conducting nonclinical studies that determine in vitro safety and efficacy, it cannot agree with an agency draft guidance on using generally
Devices
FDA has cleared a Meridian Bioscience 510(k) for its Premier HpSA FLEX for diagnosing Helicobacter pylori. The enzyme immunoassay is used to qualitatively detect H. pylori-specific antigens in fresh, frozen, or preserved human fecal specimens, according to the company. H. pylori infection is linked to several significant upper
Drugs
An FDA update on tornado damage (see earlier story) at Pfizer’s Rocky Mount, NC sterile drug manufacturing facility says it does not expect any immediate impact on drug supplies because adequate inventories are currently at hospitals and in the distribution system. The agency says the facility supplies about “8%
Drugs
FDA has released an International Council for Harmonization-developed guidance entitled “M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.” The document is intended to provide a “practical framework” for identifying, categorizing, qualifying and controlling mutagenic impurities to limit potential carcinogenic risk.
FDA Policy/General
The Biden Administration says that if HR 4368, which includes FDA’s FY 2024 spending measure, were presented to the president for signing, he would veto it. In a statement articulating the Administration’s objection to the bill, the White House says it is concerned that the cuts to FDA’
Biologics
Syndax Pharmaceuticals and Incyte say they plan to file by the end of the year a BLA for axatilimab, for use in adult and pediatric patients with chronic graft-versus-host disease (GVHD) following two or more prior lines of therapy. Just-reported pivotal trial (AGAVE-201) data showed that
Drugs
Horizon Therapeutics says a Phase 2 clinical trial evaluating daxdilimab for treating systemic lupus erythematosus (SLE) failed to show a statistically significant separation between daxdilimab and placebo on the primary endpoint. The company says the primary endpoint was the proportion of patients to achieve a British Isles Lupus Assessment Group
Devices
FDA has cleared a Nesa Medtech 510(k) for its Fibroid Mapping Reviewer Application (FMRA), intended for use by physicians to generate a 3D model of the uterus from ultrasound images to assist in the accurate diagnosis and interventional procedure planning for patients with uterine fibroids. The FMRA technology allows
Drugs
FDA has approved a Verrica Pharmaceuticals NDA for Ycanth (cantharidin) topical solution for treating molluscum contagiosum (molluscum) in adult and pediatric patients. The company says molluscum is highly contagious and is commonly transmitted in households, schools, swimming pools and other extra-curricular settings. “Since molluscum spreads through skin-to-skin
Devices
Datascope has recalled its Cardiosave Rescue IntraAortic Balloon Pumps because of the potential for unexpected shutdown. According to a recall notice, a pump shutdown may occur due to failures of tantalum capacitors in the power management board and solenoid board. This problem could lead to an unexpected interruption of therapy,
Drugs
ADC Therapeutics says it is discontinuing its Phase 2 LOTIS-9 clinical trial evaluating Zynlonta (loncastuximab tesirine-lpyl) and rituximab in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL) because the benefit-risk profile does not support its continuation. Earlier this month, ADC said that
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of an NDA for Bufferin (aspirin) tablets because the application holder has failed to file required annual reports. The NDA holder identified in FDA’s records is Bristol Myers Products, but the agency says it has received conflicting information in its attempts to
Biologics
FDA has approved an Emergent BioSolutions BLA for Cyfendus (anthrax vaccine adsorbed, adjuvanted) for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in people aged 18 through 65 years. Approval was based on data in animal models of inhalational anthrax, the company says, adding that
Devices
Former medical device regulatory affairs specialist Peter Stoll III has pleaded guilty to one felony count of violating the Federal Food, Drug, and Cosmetic Act (FDCA) by causing the introduction of misbranded and adulterated medical devices into interstate commerce. According to court documents, Stoll was responsible for making 510(k)
FDA Policy/General
After 35 years at FDA, CDER Counterterrorism and Emergency Coordination Staff (CTECS) director Rosemary Roberts is retiring this month. Roberts has served in her current position since 2004. Previously, she was the medical team leader for the Pediatrics Team and chair of the Pediatrics Subcommittee, where she worked to implement
Drugs
The Biotechnology Innovation Organization (BIO) says that FDA’s new Rare Disease Endpoint Advancement Pilot Program will provide greater clarity on how to develop novel endpoints, and it will help identify current limitations on regulatory flexibility involving the acceptance of such endpoints. In just-posted comments to FDA, BIO says
Devices
FDA has signed off on a Becton, Dickinson 510(k) that was filed over two years ago to update the firm’s troubled BD Alaris Infusion System that was the center of a cybersecurity threat and several recalls over the past few years. The agency clearance “enables both remediation and
Drugs
FDA has released the form FDA-483 issued following a 2/27-3/3 inspection at Wuxi Sta Pharmaceutical Co., a contract manufacturing organization in Wuxi, China. The one inspection observation in the document is failing to perform routine calibrations of mechanical measuring instruments according to written procedures.