Devices
FDA has approved Additive Orthopaedics’ Patient-Specific Talus Spacer, a first in the world and first of its kind 3D-printed talus implant for humanitarian use to treat avascular necrosis (AVN) of the ankle joint. An agency statement says the implant “provides a joint-sparing alternative to other surgical interventions
Devices
AdvaMed says that changes in testing requirements for electromagnetic compatibility (EMC) of medical devices should be made with advance notice and appropriate phase-in periods. In comments on an FDA draft guidance, Electromagnetic Compatibility of Medical Devices, AdvaMed says recent changes in testing requirements for in vitro diagnostic (IVD) instrumentation
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Expedited Programs for Serious Conditions — Drugs and Biologics” (OMB Control Number 0910-0765). The collection supports agency regulations and associated guidance that establish procedures designed to expedite the development, evaluation, and marketing of new therapies intended to
Devices
FDA has approved expanded MRI labeling for Medtronic’s InterStim II and InterStim Micro sacral neuromodulation (SNM) systems that use SureScan MRI leads. The updated MRI labeling allows for a wider range of MRI scan parameters and shorter wait time between MRI scans, the company says, adding that it applies
Drugs
Astellas and Seagen say they have completed submitting two sBLAs for Padcev (enfortumab vedotin-ejfv). The companies say that one submission, based on the Phase 3 EV-301 trial, seeks to convert Padcev’s accelerated approval to regular approval. The second submission, based on the pivotal trial EV-201’s
FDA Policy/General
Federal Register notice: FDA is seeking comments on recommendations by the World Health Organization to impose international manufacturing and distributing restrictions on certain drug substances. The comments received in response to the notice will be considered in preparing the U.S.’s position on these proposals for an April meeting
Biologics
FDA says that in response to a section of the 21st Century Cures Act on developing standards for regenerative medicine therapies, it is facilitating efforts to coordinate such standards development. In an online notice, the agency says it has awarded an annual contract to Nexight Group and the Standards Coordinating
Devices
FDA’s Circulatory System Devices Panel has voted not to recommend approval of BD’s Lutonix drug-coated balloon PTA (percutaneous transluminal angioplasty) catheter for treating below-the-knee lesions in patients with critical limb ischemia. Panel members voted 15 to 2 in support of the device’s safety, 2
FDA Policy/General
Federal Register notice: FDA is seeking public comments on an information collection extension associated with its “Guidance for Industry and FDA Staff — Class 2 Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle” (OMB Control Number 0910–0594)— Extension. The collection is authorized
Devices
Three SheppardMullins attorneys say a recent Federal Trade Commission (FTC) settlement highlights the importance of accurately describing how information is collected, used, and shared in digital health apps. In an online FDA Law Update Blog post, the attorneys say FTC settled with Flo Health, Inc., a fertility-tracking app, based
Devices
A 2/10 CDRH virtual town hall answered questions about the development and approval of SARS-C0V-2 (Covid-19) diagnostic tests. Office of In Vitro Diagnostics and Radiologic Health director Timothy Stenzel and associate director Toby Lowe fielded questions on issues including: * transferring ownership of an emergency use authorization;
FDA Policy/General
Federal Register notice: FDA has determined that Arbor Pharmaceuticals’ Nymalize (nimodipine) oral solution was not withdrawn from sale due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs for this reference product if all other legal and regulatory requirements are met. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has announced a 4/15 meeting of its Cellular, Tissue and Gene Therapies Advisory Committee. The panel is scheduled to discuss a CellTrans BLA for donislecel (purified allogeneic deceased donor pancreas derived islets of Langerhans), indicated for treating brittle Type 1 diabetes mellitus. The morning session
Drugs
CBER director Peter Marks says FDA is looking for ways to encourage cancer therapies to evolve quickly with enough information coming to the agency that it can be sure that patients are safe while still not holding back development. Marks spoke on a panel at a virtual meeting sponsored by
Drugs
The Justice Department says the owner of MedFitRX, now known as MedFit Sarmaceuticals, a sports supplement company based in Cary, NC, has been sentenced to one year and one day in federal prison after pleading guilty to introducing unapproved new drugs into interstate commerce. A department statement says that Brian
Devices
Attorney Matthew Decker (Duane Morris) says a 1/12 FDA action plan on the regulation of artificial intelligence and machine learning (AI/ML)-based software as a medical device (SaMD) outlines five primary goals and commitments to advance the agency’s interest in facilitating the innovation of SaMD while developing
Drugs
FDA has accepted for priority review an Amgen NDA for sotorasib for treating patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy. The submission is based on data from the Phase 2 CodeBreaK 100 clinical trial that
Drugs
FDA acting commissioner Janet Woodcock says a Public Citizen proposal to create a “firewall” between agency staff involved in any pre-submission interactions with drug sponsors and FDA staff involved in post-submission NDA or BLA review and decision-making “would cause significant repercussions for public health.” She commented in
Drugs
FDA has accepted for priority review an Amgen NDA for sotorasib for treating patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy. The submission is based on data from the Phase 2 CodeBreaK 100 clinical trial that
Drugs
Verrica Pharmaceuticals has resubmitted its NDA for VP-102 (cantharidin 0.7% topical solution), a proprietary topical therapy for treating molluscum contagiosum (molluscum). In 7/2020, FDA issued a complete response letter seeking additional chemistry, manufacturing, and controls information and human factors validation. A company notice at the time said
Devices
FDA has approved an Axonics Modulation Technologies PMA for its third-generation implantable neurostimulator. The company says the third-generation updates the software in the neurostimulator and the functionality of the patient remote control.
Biologics
FDA has accepted for review a Coherus BioSciences BLA for CHS-1420, a biosimilar to AbbVie’s Humira (adalimumab), indicated for treating rheumatoid arthritis, juvenile idiopathic arthritis (four years and older), psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis. FDA has set a user