Drugs
FDA has added information in a revised guidance about remote monitoring of clinical trials conducted during the Covid emergency and whether onsite monitoring should audit the remote monitoring once Covid restrictions are lifted. The re-monitoring discussion is contained in the appendix and the just-revised guidance entitled Conduct of
Drugs
FDA has released two new CDER Manuals of Policies and Procedures (MAPPs). The first, Scientific Interest Groups: Criteria and Policies, outlines the process and requirements for creating a scientific interest group (SIG) in the CDER Office of Clinical Pharmacology (OCP). The MAPP says a SIG is a group of volunteer
Devices
FDA has cleared a MiRus 510(k) for its IO Expandable Lumbar Interbody device for use in posterior and transforaminal fusion procedures. The device features a low insertion profile (4mm) and long expansion (18mm) in a single implant, the company says. The expandable implant, which allows for 2.5cc of
Drugs
FDA has approved a UCB expanded indication for Briviact (brivaracetam) tablets, oral solution, and injection to treat partial-onset seizures in patients as young as one month of age. The company says its data in pediatric patients includes long-term retention rates over two years. “In an open label follow-
Drugs
FDA has approved an Anixa Biosciences IND for its CAR-T (Chimeric Antigen Receptor-T cell) therapy, which is being developed in partnership with Moffitt Cancer Center, and its use in treating ovarian cancer. The autologous cell therapy comprises engineered T-cells that target the follicle stimulating hormone receptor, which
Drugs
FDA has revised its guidance entitled Conduct of Clinical Trials of Medical Products During the Covid-19 Public Health Emergency. The document provides general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity for the duration
Devices
FDA has granted de novo authorization to Zimmer Biomet and Canary Medical for their tibial extension for Persona IQ, the first smart knee for total knee replacement surgery. Persona IQ combines Zimmer Biomet’s Persona Personalized Knee, with Canary Medical's proprietary implantable canturio te tibial extension sensor technology
Drugs
FDA has granted Lantern Pharma an orphan drug designation for LP-184 and its use in treating glioblastoma multiforme (GBM) and other malignant gliomas. LP-184 is a small molecule drug candidate and next generation alkylating agent that “preferentially damages DNA in cancer cells that over-express certain biomarkers or
FDA Policy/General
Federal Register notice: FDA has announced that it has revoked the Emergency Use Authorization (EUA) issued to Curative Inc. for its Curative SARS-Cov-2 Assay based on the company’s request. The company told the agency that it has transitioned to other EUA tests to be used at its
FDA Policy/General
Federal Register notice: FDA has made available two draft device-specific guidance documents for the Safety and Performance Based Pathway — Denture Base Resins: Performance Criteria for Safety and Performance Based Pathway and Facet Screw Systems: Performance Criteria for Safety and Performance Based Pathway. To view the notice, click here.
FDA Policy/General
Breckenridge’s Solifenacin Succinate ANDA Withdrawn 8/27/2021 Federal Register notice: FDA has withdrawn the approval of a Breckenridge Pharmaceutical ANDA for solifenacin succinate tablets (5mg and 10mg) after the company requested such action. The company’s request is related to a 1/23/2020 field alert report that
FDA Policy/General
DEVICES FDA has cleared a Qiagen 510(k) for the ipsogen JAK2 RGQ PCR Kit for detecting mutations affecting the Janus Tyrosine Kinase 2 (JAK2) gene. This is the first FDA-authorized test intended to help physicians in evaluating patients for suspected Polycythemia Vera (PV), according to the agency. The
Drugs
SciClone Pharmaceuticals has agreed to be acquired for $605 million by a consortium of buyers, including GL Capital Management CP, Bank of China Group Investment, and Ascendent Capital Partners. SciClone is a specialty pharmaceutical company with significant commercial business in China. Its portfolio covers oncology, infectious diseases and cardiovascular disorders.
Drugs
Roche has decided to withdraw the accelerated approval for Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane, albumin-bound paclitaxel; nab-paclitaxel) for treating adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1. The decision, which only affects the mTNBC indication in the
FDA Policy/General
Federal Register notice: FDA has withdrawn the approval of a Breckenridge Pharmaceutical ANDA for solifenacin succinate tablets (5mg and 10mg) after the company requested such action. The company’s request is related to a 1/23/2020 field alert report that indicated the tablets may convert to solifenacin tartrate during
FDA Policy/General
Federal Register notice: CDER has announced that 10/18 is the effective date that it will begin rejecting submissions that fail either Electronic Common Technical Document (eCTD) validation 1551 or 1553, which are high severity validation errors. The validation is related to certain types of promotional material-related submissions, including
Devices
FDA has release a draft guidance entitled Facet Screw Systems — Performance Criteria for Safety and Performance Based Pathway. The screw systems that are the subject of the guidance comprise metallic bone screws and optional washer components. The devices are unclassified and are identified with the product code MRW (system, facet
Devices
FDA has posted a draft guidance entitled Denture Base Resins — Performance Criteria for Safety and Performance Based Pathway. The document provides performance criteria for denture base resins for those using the pathway to market. Under the framework, 510(k) submitters have the option to use the performance criteria proposed in
Devices
A new study by FDA researchers supports an agency recommendation earlier this year that patients keep any consumer electronic devices that may create magnetic interference, including cell phones and smart watches, at least six inches away from implanted medical devices, especially pacemakers and cardiac defibrillators. The study, published by the
Devices
FDA has approved a MicroTransponder PMA for the Vivistim Paired VNS System, a rehabilitation device intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke using vagus nerve stimulation (VNS). “To use the Vivistim System, an implantable pulse generator (IPG) — which generates a mild electrical
FDA Policy/General
Federal Register notice: FDA has announced the renewal of its Nonprescription Drugs Advisory Committee for an additional two years. The new charter will be in effect until 8/27/2023. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced an 11/2-3 Medical Devices Advisory Committee Circulatory System Devices Panel meeting. On 11/2, panel members are scheduled to discuss and make recommendations on information about the Endologix AFX endovascular graft system’s benefit-risk profile regarding Type 3 endoleaks. On 11/