Devices
Fujirebio Diagnostics has submitted a 510(k) for the Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test for use in assessing Alzheimer’s disease. The test uses Fujirebio’s automated Lumipulse G1200 instrument system to analyze results. According to Fujirebio, the device combines the concentrations
Devices
FDA has posted the transcript from a 10/27 CDRH public meeting on reauthorizing the Medical Device User Fee Act (MDUFA) program. During the meeting, FDA commissioner Stephen Hahn acknowledged the resource strain from the current Covid-19 emergency on the Center’s ability to continue to meet user fee
Drugs
FDA says it is accepting research proposals focused on assessing the impact of extended-infusion of beta-lactam antibacterial drugs on the development of beta-lactam resistance and patient outcomes. Specifically, a notice (includes a link to the research announcement) says, the agency will prioritize research proposals focused on evaluating
Drugs
FDA has granted AlloMek Therapeutics an orphan-drug designation for its macrocyclic MEK kinase inhibitor, CIP-137401, for treating neurofibromatosis Type 1 (NF1). The drug has been tested in an established NF1 preclinical model and was found to reduce both absolute tumor numbers and the size of plexiform neurofibromas, the
Drugs
FDA has granted Mesoblast Ltd. a Fast Track designation for remestemcel-L for treating acute respiratory distress syndrome (ARDS) due to Covid-19 infection. The designation is based on clinical data from a pilot study of remestemcel-L under emergency compassionate use at New York’s Mount Sinai Hospital earlier
Drugs
The Association for Accessible Medicines (AAM) says an FDA draft guidance on failure to respond to an ANDA complete response letter (CRL) within the regulatory timeframe raises some questions for which the association is seeking further clarification from the agency. The association’s comment letter says the guidance says that
Drugs
A citizen petition submitted on behalf of Pharmaceutical Research and Manufacturers of America (PhRMA) calls on FDA and HHS to take several steps to stop the drug import program recently announced by the Trump administration. PhRMA was one of three groups that recently filed suit in federal court to block
Drugs
AbbVie says FDA should modify its draft guidance on using physiologically based pharmacokinetic (PBPK) analyses in biopharmaceutics applications for oral drug product development, manufacturing changes and controls, to include recommendations for PBPK model-based biowaivers or safe-space applications in cases where permeability is the limiting factor controlling the appearance
Devices
The Association for the Advancement of Medical Instrumentation (AAMI) has published a consensus report with guidelines for implementing remote control for many critical medical devices during the Covid-19 pandemic. An AAMI announcement (includes a link to the guidelines) says FDA has already issued emergency use authorizations for many remote
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Good Laboratory Practice for Nonclinical Laboratory Studies — 21 CFR Part 58” (OMB Control Number 0910–0119). The collection supports agency regulations that specify minimum standards for the proper conduct of safety testing and contains sections on facilities,
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Electronic Records; Electronic Signatures — 21 CFR Part 11” (OMB Control Number 0910–0303). The collection supports FDA’s acceptance of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records. To
FDA Policy/General
Federal Register notice: FDA is reopening the comment period for and providing additional information and analysis on a 5/31/2019 notice entitled “Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain.” The notice described a potential modification to the Opioid
Drugs
An FDA 2/19-2/21 inspection at ForYou, Inc., Loris, SC, found significant violations of current good manufacturing practice (CGMP) regulations for dietary supplements, among other violations. A just-released 10/20 Warning Letter says several of the firm’s products are considered to be unapproved new drugs and
Devices
The Medical Device Innovation Consortium (MDIC) says it has formed a Working Group, sought by FDA, focusing on 5G-enabled health technologies. MDIC says working group stakeholders are subject matter experts and senior-level executives from medical device manufacturers, 5G network operators, 5G chipset and network equipment manufacturers, wireless service
Drugs
FDA has approved Gallium 68 PSMA-11 (Ga 68 PSMA-11), the first drug for positron emission tomography imaging of prostate-specific membrane antigen positive lesions in men with prostate cancer. The approval was granted to UCLA and the University of California, San Francisco. An agency statement says Ga 68
Devices
FDA says its review of the Industry Lab Diagnostic Partners Web site determined that the firm is offering a Covid-19 at-home sample collection kit that is considered a medical device that is being marketed without marketing approval, clearance, or authorization from the agency. An 11/20 Warning Letter
Devices
Baxter Healthcare is recalling its Sigma Spectrum Infusion Pumps with Master Drug Library (V6, V8) and the Baxter Spectrum IQ Infusion Systems with Dose IQ Safety Software (V9) because improper cleaning may lead to residue build-up or corrosion on the device. “If the device is running only on battery
Drugs
FDA has approved a Genentech supplemental BLA for Xolair (omalizumab) for the add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. “With Xolair, we observed significantly reduced nasal polyps and congestion symptoms in adults who had nasal
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications. The document focuses on specific recommendations pertinent to gastric pH-dependent drug-drug interaction (DDI) assessments and describes the agency’s
FDA Policy/General
President Trump had his chief of staff Mark Meadows summon FDA commissioner Stephen Hahn to the White House 12/1 to learn why the agency has not approved or authorized the use of Covid-19 vaccines after promising data was recently reported on their efficacy. Despite the appearance of political
Devices
FDA has recognized A2LA, a non-governmental third-party accreditation body, as a participant in the Accreditation Scheme for Conformity Assessment (ASCA) pilot program. With FDA recognition, A2LA will be able to assess testing laboratories seeking ASCA accreditation to perform a premarket assessment for medical device companies.
Drugs
Minerva Neurosciences says that following a meeting with FDA on the data package and readiness to support an NDA of its roluperidone to treat negative symptoms in schizophrenia, it is continuing its development and NDA activities. Minerva says it had asked the agency to confirm that data from a Phase