Devices
The Sedgwick Recall Index for the second quarter of 2022 says that medical device recalls hit a two-year high with 268 events, up 34% from the 200 recalls in the first quarter. However, the report says, the number of affected units dropped by 96.8% to 10.1 million
Drugs
FDA has released the form FDA-483 issued following a 9/13-9/30 inspection at the Qualgen sterile drug production facility in Edmond, OK. The nine inspection observations were: * failing to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit; * failing to
Devices
FDA has approved an Enovis PMA for the STAR Patient Specific Instrumentation (STAR PSI System) and its use with the company’s STAR total ankle replacement system. The new device provides a personalized pre-operative plan for each patient, Enovis says, including a 3D visualization of the patient’s ankle
FDA Policy/General
Federal Register notice: HHS has delegated to FDA and NIH authorities under the Accelerating Access to Critical Therapies for ALS [amyotrophic lateral sclerosis; aka Lou Gehrig’s Disease] Act to establish and implement a Public-Private Partnership for rare neurodegenerative diseases. In September, FDA and NIH announced the launch of
Devices
Ombu Enterprises is petitioning FDA to take administrative action to make unique device identifier (UDI) information publicly available in the MAUDE (Manufacturer and User Facility Device Experience) database and the Recall database. The petition says one significant role of publicly available elements in the databases is to provide specific information
Drugs
A bipartisan letter from four senators is urging FDA commissioner Robert Califf and HHS secretary Xavier Becerra to step up efforts to help resolve amoxicillin and other drug shortages. “The record high levels of respiratory illnesses have spiked demand for amoxicillin and other essential medicines, and patients and providers continue
Biologics
FDA has granted in part and denied in part a 7/2/20 petition submitted by the Microbiome Therapeutic Innovation Group (MTIG) asking the agency to take certain actions regarding fecal microbiota for transplantation (FMT) to treat Clostridium difficile infection. The agency’s 11/29 response says MTIG sought these
Drugs
FDA has accepted for priority review a Regeneron Pharmaceuticals supplemental BLA for Evkeeza (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 years with homozygous familial hypercholesterolemia (HoFH). The agency has set a user fee review action date of 3/30/2023.
FDA Policy/General
Federal Register notice: FDA is requesting nominations for voting members to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee. Nominations are being accepted for current and upcoming vacancies effective 1/1/2023. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available draft guidance #276 entitled “Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.” The document provides recommendations for the effectiveness evaluation of drugs indicated for preventing heartworm disease caused by Dirofilaria immitis in dogs. To view
Drugs
The Department of Justice says two owners of Synergy Medical, based in New Jersey, have admitted before a federal judge their roles in a $38 million compounded medication healthcare fraud scheme. A department statement says Samantha Zaretsky, of Wayne, NJ, and Lee Nichols, of Fair Haven, NJ, each pleaded guilty
Devices
Friends of Cancer Research CEO Jeff Allen and American Cancer Society Action Network president Lisa Lacasse say Congress should pass the VALID (Verifying Accurate Leading-edge IVCT Development) Act to “set a clear, modernized regulatory framework to ensure that any test, no matter where it is developed, meets the same
Biologics
Janssen has filed a patent infringement suit in Delaware federal court against Amgen and its plans to seek FDA approval and market a biosimilar copy of Janssen’s blockbuster Stelara (ustekinumab), indicated for treating plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Earlier this month, Amgen provided Janssen
Drugs
Merck has filed suit in Maryland federal court claiming that Johns Hopkins University (JHU) improperly obtained patents that emerged from a research collaboration between the two for Merck’s cancer drug Keytruda (pembrolizumab). The suit says Merck and JHU partnered to design and conduct a clinical study administering Keytruda to
Drugs
FDA says Lilly’s bebtelovimab is not currently authorized for emergency use in the U.S. because it is not expected to neutralize two prevalent Omicron subvariants. An agency statement says the company and its authorized distributors have paused the commercial distribution of bebtelovimab until further notice from FDA. The
Drugs
Eisai and Biogen are reporting new data from a lecanemab Alzheimer’s Phase 3 trial that suggest treated patients with early Alzheimer’s disease had reduced brain amyloid levels and moderately less decline on clinical measures of cognition and function than patients on placebo at 18 months, but they experienced
Drugs
FDA has approved Ferring Pharmaceuticals’ Rebyota (fecal microbiota) for preventing recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older. It is for use after an individual has completed antibiotic treatment for recurrent CDI, an agency release says. FDA says Rebyota is prepared from stool donated
Devices
A former Becton Dickinson (BD) medical director and safety monitor has petitioned FDA to refer the company to the U.S. Justice Department for allegedly violating the False Claims Act related to a safety defect with the company’s 510(k)-cleared Genesis Sterilization Containers. The devices are intended to
Drugs
A 4/12-4/20 FDA inspection at Arbor Centers for EyeCare (David Lubeck, MD), Orland Park, IL, identified objectionable conditions in the center’s work as sponsor/investigator for two clinical investigations. An 11/18 Warning Letter says the inspection was conducted as part of the agency’s Bioresearch
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridioides difficile Infection Not Responsive to Standard Therapies.” The document describes the agency’s intended enforcement discretion with respect to IND requirements for
Drugs
Lexicon Pharmaceuticals says a CDER proposed order to delay a hearing and deny approval of the company’s NDA for sotagliflozin oral tablets to treat Type 1 diabetes mellitus (T1DM) “is unfounded based on the facts of the data presented by Lexicon: an effective drug for TIDM, with additional efficacy
Drugs
Several stakeholders are suggesting ways they believe an FDA draft regulation on nonprescription drug products with an additional condition for nonprescription use (ACNU) can be improved. Public Citizen Health Research Group says concerns raised by stakeholders in countries in which pharmacists enable patients to get medicines without a doctor’s