Biologics
FDA has published a guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers, with help for sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties on using electronic systems, records, and signatures in clinical investigations of medical products, new animal drugs,
Drugs
FDA has released the form FDA-483 issued following a 7/15-8/2 inspection at ProRx, an Exton, PA, outsourcing facility. The 13 inspection observations were: * failure to establish, write, and follow procedures to prevent microbiological contamination of drug products purporting to be sterile; * failure to include adequate validation
Biologics
FDA has approved Fresenius Kabi and Formycon’s biosimilar Otulfi (ustekinumab-aauz), a copy of Johnson & Johnson’s referenced Stelara, for treating Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. The biosimilar was approved for both subcutaneous and intravenous formulations. Ustekinumab is described
Drugs
Sen. Bill Cassidy (R-LA) is asking FDA to explain why it has failed to provide clarity to drug manufacturers on properly listing their products’ patents in the Orange Book. In a 9/30 letter to FDA commissioner Robert Califf, Cassidy says that for decades, brand and generic drug manufacturers
Drugs
A 5/6-5/16 FDA inspection at the Diamond Chemical Co. drug manufacturing facility in East Rutherford, NJ, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 9/6 Warning Letter says specific violations were: * failure to test samples of each component
FDA Policy/General
Today (10/1) marks the beginning of a new model for FDA inspections as part of a reorganization that was brought on by the 2022 infant formula debacle (see FDA Webview 1/2023 and 4/2022) FDA’s Office of Regulatory Affairs has been renamed the Office of Inspections and
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) plans to study the promotion of prescription drugs in a talk show format. A Federal Register notice says the research will look at advertising features through what is known as “native advertising,” a form of advertisement where marketers present paid content in
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Electronic User Fee Payment Request Forms — Form FDA 3913 and Form FDA 3914.” Form FDA 3913 was crafted to provide the minimum necessary information for FDA to review and process a user fee payment refund. Form FDA
Drugs
Following four fatalities, Kezar Life Sciences has suspended the enrollment of new patients and dosing of ongoing patients in its Phase 2b PALIZADE trial evaluating two dose levels of zetomipzomib (30mg and 60mg) in patients with active lupus nephritis. The suspension resulted from a safety data review by an independent
FDA Policy/General
Federal Register notice: FDA is making available four final device-specific guidance documents for the Safety and Performance Based Pathway. They address performance criteria of air-powered dental handpieces and air motors, dental ceramics, dental impression materials, and dental cements. Under the pathway, a new device could come to market
Biologics
Johnson & Johnson has submitted a supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) for a new indication — combination use with bortezomib, lenalidomide and dexamethasone (D-VRd) for treating adults with newly diagnosed multiple myeloma for whom autologous stem cell transplant is deferred or not appropriate. The filing is
Drugs
Smiths Medical has recalled (Class 1 device correction) its ParaPAC Plus P300 and P310 Ventilators due to inadvertent tidal volume knob movement. “When the knob is set at high (1,000 – 1,500 ml) or low (70 - 150 ml), the knob may move away from the original setting on its
Drugs
FDA has granted a de novo marketing clearance for Germitec’s Chronos automated disinfection device for reducing the risk of cross-contamination. The one-button, chemical-free automated device uses UV-C technology to “penetrate the membrane of microorganisms, disrupting their DNA, RNA, and cellular proteins, thereby halting their replication
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment.” The document provides clarification on recordkeeping, reporting, manufacturing, importing, and installation for an FDA-regulated electronic product. To view the notice, click here.
FDA Policy/General
FDA is outlining areas it feels can be optimized to help improve the advice received from advisory committee meetings. Writing in the 9/30 journal Nature, FDA commissioner Robert Califf and other top officials say they plan to refine the areas through future public engagements. One of the top focus
Devices
FDA has approved Establishment Labs Holdings’ Motiva SmoothSilk Ergonomix and Motiva SmoothSilk Round breast implants for primary and revision breast augmentation. The devices feature the patented SmoothSilk surface, which is designed for “enhanced biocompatibility and scientifically shown to promote low inflammation,” the company says. The Motiva SmoothSilk Ergonomix device is
Devices
CDRH has issued four dental final guidances under its Performance Criteria for Safety and Performance Based Pathway program. They are: 1. Dental Air-Powered Dental Handpieces and Air Motors 2. Dental Cements 3. Dental Ceramics 4. Dental Impression Materials CDRH says that under the pathway, device manufacturers planning to submit
Drugs
FDA has approved Sanofi and Regeneron’s Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Approval is based on data from two landmark pivotal Phase 3 studies (BOREAS and NOTUS) that evaluated the efficacy and safety
Drugs
FDA has approved Bristol-Myers Squibb’s Cobenfy (xanomeline and trospium chloride) capsules for treating schizophrenia in adults. The approval marks a major shift in treating the condition as Cobenfy is the first drug to target cholinergic receptors, rather than dopamine receptors, which have long been the standard of care
FDA Policy/General
Federal Register notice: FDA is seeking consumer organizations interested in participating in the selection process for voting or nonvoting consumer representatives to serve on its advisory committees or panels. Interested parties are encouraged to notify the agency in writing. FDA is also requesting nominations for voting or nonvoting consumer representatives
FDA Policy/General
Federal Register notice: FDA is announcing four information collections that have been approved by OMB. They are: * Biological Products; General Records and Postmarket Adverse Experience Reporting * Voluntary Total Product Life Cycle Advisory Program Pilot * New Plant Varieties Intended for Food Use * Food and Cosmetic Export Certificates To view the notice,
Biologics
The U.S. 9th Circuit Court of Appeals in San Francisco has reversed an 8/2022 California lower court decision (see earlier story) that ruled a stem cell treatment firm was exempt from FDA regulations. The lower court had declined to block California Stem Cell Treatment Center from continuing to