FDA Policy/General
Federal Register notice: FDA has issued a final guidance entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.” The document outlines how the agency plans to identify whether responsible parties have failed to submit required clinical trial registration or results information to ClinicalTrials.gov. It also discusses how
Devices
FDA is alerting clinical laboratory staff and health care providers about a risk of false results with Thermo Fisher Scientific TaqPath Covid-19 Combo Kit based on two issues related to the test kit and its associated Applied Biosystems Covid-19 Interpretive Software. The test is a molecular assay for
Drugs
FDA has accepted for review a Myovant Sciences NDA for its once-daily, oral relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for treating women with heavy menstrual bleeding associated with uterine fibroids. The agency has set a user fee review action
Drugs
FDA has approved a Genentech BLA for Enspryng (satralizumab-mwge) for treating neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular antibody – those who are anti-aquaporin-4 antibody-positive. NMOSD is a central nervous system rare autoimmune disease that largely affects the optic nerves and spinal cord. “In
FDA Policy/General
Federal Register notice: FDA is proposing to reclassify non-invasive bone growth stimulators from postamendments Class 3 devices into Class 2 (premarket notification). Non-invasive bone growth stimulator devices provide stimulation through electrical and magnetic fields to facilitate the healing of nonunion fractures and lumbar spinal fusions. To view the
Biologics
CBER’s Office of Compliance and Biologics Quality has sent East West Health Solutions (Lake City, UT) an untitled letter based on a review of the company’s Web site, www.acueastwest.com, and other online sources. The review determined that the company was marketing unapproved cellular products derived from
Drugs
FDA has issued a final guidance entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.” The document outlines how the agency plans to identify whether responsible parties have failed to submit required clinical trial registration or results information to ClinicalTrials.gov. It also discusses how it will identify
FDA Policy/General
Federal Register notice: FDA has amended a 7/23 notice about a 9/15 Pediatric Advisory Committee meeting. The amendment reflects a change in the procedure portion of the notice — oral presentations from the public will be scheduled between 11:30 am to 12:30 pm eastern time. To view
FDA Policy/General
Federal Register notice: FDA has made available two final device-specific guidance documents for its Safety and Performance Based Pathway: “Cutaneous Electrode for Recording Purposes — Performance Criteria for Safety and Performance Based Pathway” and “Conventional Foley Catheters — Performance Criteria for Safety and Performance Based Pathway.” To view the notice, click
Devices
FDA has posted a device shortage list which was mandated as part of the recent coronavirus-related CARES Act. The listing reflects devices that FDA has determined to be in shortage and will be updated as the Covid-19 pandemic evolves. In addition, the agency includes a listing of medical
Devices
The 9th Circuit Court of Appeals has rejected device preemption arguments from C.R. Bard in a product liability lawsuit involving the company’s G2 Intravascular Filter. The panel of judges affirmed a lower court’s ruling in favor of the plaintiff and rejected Bard’s motion for summary judgment
Biologics
FDA’s Oncologic Drugs Advisory Committee has voted nine to one in favor of approving a Mesoblast BLA for Ryoncil (remestemcell-L) as a treatment for steroid-refractory acute Graft Versus Host Disease in pediatric patients. The positive vote followed briefing documents released by FDA in advance of the meeting
Devices
FDA has issued two final guidances providing performance criteria for conventional foley catheters and cutaneous electrodes for recording purposes in support of the safety and performance-based pathway. The agency says that under the pathway, medical device manufacturers planning to submit a 510(k) for the devices have the option
Drugs
CDER researchers say that although pain intensity has been the primary outcome measure in clinical trials for pain, an array of measures assessing clinical outcomes from multiple perspectives can allow for a more comprehensive interpretation of how a treatment affects patients’ lives. Writing in Neurotherapeutics, the researchers say that careful
Drugs
FDA is asking the United States Pharmacopeia (USP) not to reach any conclusion on including disregard limits/drug thresholds in drug substance and drug product monographs as proposed by the USP 8/13/19. A just-released FDA 7/31 comment letter gives the agency’s rationale and reasons for
Devices
FDA has published two frequently asked questions documents relating to medical device issues during the Covid-19 pandemic. Registration and Listing of Medical Devices During the Covid-19 Pandemic provides information for medical device establishments, including owners and operators of places of business that are involved in the production and
Devices
FDA has cleared a RapidAI 510(k) for the Rapid LVO for detecting suspected large vessel occlusions (LVOs). The device, which provides results in about three minutes, uses a vessel tracker in conjunction with an assessment of brain regions with reduced blood vessel density to identify suspected LVOs with a
Devices
FDA has cleared Deep Blue Medical Advances’ 510(k) for its T-Line hernia mesh with integrated suture-like extensions. The company says the product provides superior anchoring strength and eliminates a key point of failure for conventional mesh fixation — the mesh/suture/tissue interface. Deep Blue says it expects
Drugs
FDA has accepted a Novartis supplemental BLA for a new self-administration option for Xolair (omalizumab), which is designed to target and block immunoglobulin E (IgE) for treating patients with moderate to severe persistent allergic asthma and chronic idiopathic urticaria. Currently, the therapy is approved only for administration by a
Drugs
FDA has accepted a TG Therapeutics NDA for umbralisib, a once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon for treating patients with previously treated marginal zone lymphoma who have received at least one prior anti-CD20 based regimen and patients with follicular lymphoma who have received at
FDA Policy/General
Federal Register notice: FDA has announced a 10/30 public workshop entitled “New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation.” The workshop provides an opportunity for public comments/feedback on the “integrated review” documentation generated by the new assessment of marketing
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment.” The document addresses FDA’s current thinking on the overall development program and clinical trial designs for developing drugs and biological products to support an indication for treating AML,