Devices
FDA has provided an update on its ongoing monitoring of heater-cooler devices and the risk of nontuberculous mycobacteria infections in patients who have undergone cardiothoracic surgery using the devices. The agency says that last month it cleared the Spectrum Medical Quantum Heater-Cooler and the compatible Qura Quantum PureFlow
FDA Policy/General
Federal Register notice: FDA has renewed its Science Advisory Board to the National Center for Toxicological Research for an additional two years beyond the charter expiration date. The new charter will be in effect until 6/2/2024. To view the notice, click here.
Drugs
A February inspection at Rentschler Biopharma’s German drug substance manufacturing plant has resulted in a nine-item FDA-483 that cites significant GMP violations. For example, FDA said the fill process is not controlled to an established specification. It also found the firm’s laboratory procedures for testing to
Drugs
Health Canada has given Amylyx Pharmaceuticals its first worldwide approval for Albrioza (sodium phenylbutyrate and ursodoxicoltaurine), with conditions, for treating amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s Disease. “Clinical data demonstrated a statistically significant and clinically meaningful benefit in functional outcomes for people with ALS taking Albrioza
Devices
FDA has cleared an Ekso Bionics Holdings 510(k) to market its EksoNR robotic exoskeleton for use with multiple sclerosis patients. The device was cleared for stroke and spinal cord injury rehabilitation in 2016, and acquired brain injury in 2020. It features software to customize motor support strength for various
Drugs
FDA has removed a clinical hold on Homology Medicines and its pheNIX gene therapy clinical trial evaluating HMI-102 in adults with phenylketonuria (PKU). Homology says it is planning to inform clinical trial sites about changes to the protocol, which include a new steroid-sparing immunosuppression regimen that incorporates a
Drugs
FDA has approved an Eli Lilly supplemental NDA for Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, an autoimmune disorder that presents with baldness patches. The Janus kinase (JAK) inhibitor works by blocking the “activity of one or more of a specific family of enzymes, interfering
FDA Policy/General
Federal Register notice: FDA is correcting a 5/24 notice on a draft guidance being made available entitled “Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy” due to an incorrect comment period due date. It should have read that either electronic or written comments on the draft guidance are
Biologics
FDA briefing documents for its advisory committee review on 6/14-15 of the Pfizer-BioNTech and Moderna Covid-19 vaccines show that they are both safe and effective in children aged six years and younger. In the Pfizer vaccine, vaccine efficacy was observed at 75.6% in trial participants
FDA Policy/General
Federal Register notice: FDA is extending the comment period for a 2/16 notice that requested comments on antimicrobial drug use practices in companion animals and the potential impacts of such uses on antimicrobial resistance in both humans and animals. Comments should now be submitted by 9/14. To view
Drugs
A new JAMA online study finds that FDA is approving new oncology therapies much faster and sooner than its European regulatory counterparts. According to its findings, the study found that 89 new oncology therapies were approved by both FDA and the EMA from 2010 to 2019, but the U.S.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Food Labeling: Notification Procedures for Statements on Dietary Supplements — 21 CFR 101.93.” The collection supports FDA regulations that require supplement makers to provide the agency information related to supplement products being marketed/distributed. To view the
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Tropical Disease Priority Review Vouchers.” The collection supports agency regulations intended to encourage development of new drug or biological products for preventing and treating certain tropical diseases affecting millions of people throughout the world. The vouchers are
Drugs
GSK has announced positive data from a pre-specified efficacy interim analysis of its AReSVi 006 Phase 3 trial evaluating the company’s respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above. The analysis found that the primary endpoint was exceeded with no unexpected safety concerns
Drugs
An FDA January inspection at Bioiberica (Barcelona, Spain) resulted in a five-item FDA-483 that cited significant GMP violations at the drug substance manufacturing facility. For example, the 483 said the firm’s cleaning procedures for manufacturing equipment were not validated to facilitate adequate cleaning and contamination prevention measures.
Drugs
CBER has updated its prioritization schedule for the remainder of 2022 to account for Covid-19-related work. For the remainder of the year, the Center will continue to prioritize resources for Covid-19 regulatory work over non-Covid work, as needed. “As we enter calendar year 2023, we plan
Devices
FDA has updated a Class 1 recall notice involving Woodside Acquisitions’ Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit and the Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold). The notice says the firm’s name does not appear on the tests’ labels. It also clarifies that
Devices
FDA has granted an emergency use authorization (EUA) for Laboratory Corp. of America’s VirSeq SARS-CoV-2 NGS Test on the PacBio Sequel II sequencing system. The test addresses the need to identify Covid-19 mutations that have resulted in genetic variation in circulating virus strains, also called lineages.
Drugs
Green Pharmaceuticals has recalled one lot of its SnoreStop NasoSpray after FDA testing found the product contained a microbial contamination identified as Providencia rettgeri. A recall notice says that while the microorganism is rarely associated with human illness, immunocompromised patients are at risk of severe or life-threatening adverse events,
Devices
FDA has cleared Thermo Scientific 510(k)s for its EliA RNA Pol III and EliA Rib-P tests for aiding in the diagnosis of systemic sclerosis (SSc; scleroderma) and systemic lupus erythematosus (SLE). “RNA Polymerase III is a criteria marker for SSc with both diagnostic and prognostic value,” the
FDA Policy/General
While declining to intervene in a whistleblower case involving Trividia Health blood glucose meters, the Department of Justice (DoJ) has filed a “statement of interest” with a Florida federal court that provides a “vigorous defense” of the “fraud-on-FDA” theory of liability. Writing in Sidley’s False Claims Act
Drugs
An FDA consumer update cautions that some products marketed for removing moles and other skin lesions can cause injuries and scarring. The online post says there currently are no FDA-approved prescription or over-the-counter drugs to treat moles, seborrheic keratoses, or skin tags. “But,” it says, “there are