Drugs
FDA says a Web site and Facebook page operated by SilveryGuy from Singapore is selling unapproved and misbranded colloidal silver representing or implying that the product can mitigate, prevent, treat, diagnose, or cure Covid-19 in people. An 8/14 Warning Letter gives several of the Web site and social
Drugs
CDER has issued a Manual of Policies and Procedures, Notifying Applicants of Sentinel Analyses and Results, describing the policies and procedures followed by the Office of Surveillance and Epidemiology for notifying an applicant or holder of an NDA or BLA about certain types of safety studies conducted in the Sentinel
Devices
FDA has announced an 11/13 public workshop entitled “Orthopedic Device-Related Infections.” The agency says the workshop is the first of a series planned to improve public understanding of infections related to orthopedic devices and appropriate mitigation measures for protecting and promoting public health in this clinical area. It
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. AkivaMed, U.S. (7/23): FDA recently reviewed the company’s Web site (www.akivamed.com) and determined that its “Covid-19 Antibody Rapid Test Kit” marketed to consumers
Drugs
The federal government has filed a False Claims Act complaint charging that Teva illegally paid Medicare co-pays for the multiple sclerosis drug Copaxone through purportedly independent foundations that were used as conduits in violation of the anti-kickback law. The Department of Justice (DoJ) says the company used the
Drugs
FDA has granted AstraZeneca a priority review for its supplemental BLA for Imfinzi (durvalumab) and a new four-week, fixed-dose regimen for treating approved indications for non-small cell lung cancer (NSCLC) and bladder cancer. If approved, the drug could be administered intravenously every four weeks at a fixed
Drugs
FDA has placed a clinical hold on a Poseida Therapeutics Phase 1 clinical trial for its P-PSMA-101 in metastatic castrate-resistant prostate cancer. In a Securities and Exchange Commission notice, the company says it paused enrollment in the trial to investigate a patient's death. The notice
Devices
FDA has cleared a 23andMe 510(k) for a pharmacogenetics report on interpretive drug information for two drugs — heart drug clopidogrel and depression drug citalopram. The clearance modifies the labeling of the company’s 23andMe CYP2C19 Drug Metabolism Report, removing the need for confirmatory testing and allowing the company to
Devices
FDA has posted a catalog of regulatory science tools to help sponsors assess new medical devices. The catalog “collates a variety of regulatory science tools” that CDRH’s Office of Science and Engineering Labs developed and plans to expand as new tools become available. The tools include: * Laboratory methods * Computational
Devices
FDA has issued an emergency use authorization to Yale School of Public Health for its SalivaDirect Covid-19 diagnostic test. The test does not require any special swab or collection device; a saliva sample can be collected in any sterile container, an FDA release says. It is also “unique” because
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Food and Drug Administration Rapid Response Surveys” (OMB Control Number 0910-0500). The collection covers surveys for community-based healthcare professionals, general type medical facilities, specialized medical facilities, patients, consumers, and risk managers working in facilities containing
Drugs
President Trump reportedly has turned some attention to an extract from the oleander plant as an unproven cure for Covid-19, and he may be quietly urging FDA to help get the product on the market as a dietary supplement or a new drug, according to a report from Axios.
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