Drugs
FDA has approved a Curis IND application for CI-8993, which it describes as the first-in-class monoclonal anti-Vista antibody. A Phase 1a/1b study of CI-8993 is planned for the second half of the year. The multi-center, open-label dose escalation study will evaluate about
Drugs
FDA has cleared a 4Web Medical 510(k) to market its Stand-Alone Anterior Lumbar Interbody Fusion Device. It is designed to allow fixation screws to be placed through the truss implant and into the adjacent vertebral bodies creating a zero-profile stand-alone construct that removes the need for
Drugs
FDA and the National Center for Advancing Translational Sciences at the National Institutes of Health say they have updated the CURE ID app to make it a more effective tool during the Covid-19 public health emergency. A joint statement describes CURE ID as an Internet-based repository that allows
Drugs
University of Minnesota School of Public Health professor Leigh Turner says FDA needs to become much more transparent about the operations of its new Coronavirus Treatment Acceleration Program (CTAP). In an online post at The Conversation, Turner says that “as a specialist in bioethics and public health, I see troubling
Drugs
AbbVie and Genmab have announced a collaboration agreement to jointly develop and commercialize three of Genmab’s early-stage investigational bispecific antibody product candidates and enter into a discovery research collaboration for future differentiated antibody therapeutics for cancer. The companies say they will partner to develop epcoritamab (DuoBody-CD3xCD20), DuoHexaBody-
Devices
FDA has issued an emergency use authorization to Illumina, Inc., for the first Covid-19 diagnostic test using next-generation sequencing technology. An agency statement says FDA authorized the Illumina COVIDSeq test for the qualitative detection of SARS-CoV-2 RNA from respiratory specimens collected from individuals suspected of Covid-
Biologics
CBER director Peter Marks told a Biotechnology Innovation Organization virtual meeting that regulators such as FDA, the European Medicines Agency (EMA), and Health Canada are working together to reach an agreement on how clinical trials should be designed and conducted for coronavirus vaccines. “Because it’s such a bad pandemic,
Devices
FDA says that all radiation safety reports may now be submitted to CDRH by email to the [email protected] mailbox. These include all report types, such as product reports, annual reports, and supplemental reports of all types, and all communications such as notifications of defect/failure to comply,
Devices
FDA has cleared an Atomic Blue 510(k) for its high-performance UV-C germicidal light for commercial use in eradicating the Covid-19 virus from surfaces. The device has been registered with the agency as a disinfectant medical device with the product code LRJ. “When biological organisms are exposed
Drugs
FDA and the U.S. Commerce Department’s National Telecommunications and Information Administration (NTIA) have begun a 120-day pilot to help reduce unapproved opioids illegally offered for sale online. Under the pilot, the agency will notify internet registries that are participating in the pilot – Neustar, Verisign and Public Interest
Drugs
FDA and HealthVerity have entered into a multi-year research collaboration agreement to evaluate a range of different real-world datasets for their potential to inform the agency’s response to Covid-19. Earlier this month, FDA commissioner Stephen Hahn said it is time to look forward and evaluate the
Drugs
FDA has warned the owners of a Web site operating at chloroquineonline.com that they are offering drug products for sale in the U.S. that are intended to mitigate, prevent, treat, diagnose, or cure Covid-19. A 5/18 Warning Letter says such products are legally considered to be
Devices
FDA has cleared a Sekisui Diagnostics 510(k) for the Osom Ultra Plus Flu A&B Test and its use in the qualitative detection of influenza Type A and Type B nucleoprotein antigens directly from nasal or nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection.
Drugs
Six Hogan Lovells attorneys say the 6/4 FDA update to the Compliance Program Guidance Manual (CPGM) includes a program for inspecting CDER-led and CDRH-led combination products. In an online post, the attorneys write that the updated manual says it “focuses on inspections of combination product manufacturers of
Drugs
Researchers from FDA and several drug companies summarized FDA’s past acceptance of real-world data sources for supporting drug approval in new indications that have been reflected in U.S. labels. Writing in Therapeutic Innovation & Regulatory Science, the researchers say their summary focuses on the type of real-
Drugs
The White House Office of Management and Budget (OMB) reportedly is reviewing an FDA document, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research,” that industry executives hope represents progress in the agency’s examination of whether and how to regulate the market for CBD (cannabidiol) in dietary supplements
Drugs
Academic researchers from Northwestern University and Smith College say the number of sex-inclusive research studies has significantly increased across most biological disciplines since the National Institutes of Health implemented a 2016 policy requiring investigators to consider sex as a biological variable. Writing in eLife, the researchers say while their
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: chloroquineonline.com (5/18): FDA has warned the owners of chloroquineonline.com that they are offering drug products for sale in the
Drugs
FDA is walking back misleading testimony it gave the Senate about U.S. production of active pharmaceutical ingredients (APIs). Late last year, CDER director Janet Woodcock testified before an Energy and Commerce Committee hearing that FDA does not know the volume of APIs being manufactured abroad, but last week CDER
Drugs
The Americans for Homeopathy Choice Foundation is asking FDA to issue a proposed regulation drafted by the foundation on “Homeopathic Drugs and Drugs Labeled ‘Homeopathic.’” The 6/5 petition says the foundation wants FDA to establish regulations that assure consumers that drug products labeled homeopathic are either included in the
Drugs
Senators Mike Braun (R-IN), Lisa Murkowski (R-AK), and Martha McSally (R-AZ) have introduced the Promising Pathway Act (S. 3872) that would establish a rolling, real-time, priority review pathway to evaluate provisional approval applications for drugs intended to treat, prevent, or diagnose serious or life-threatening diseases
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency.” The document provides recommendations regarding the key factors and procedures IRBs should consider when reviewing