Drugs
FDA is alerting health care professionals about the risk of inadvertent intrathecal administration with tranexamic acid injection, which may result in serious life-threatening injuries, including seizures, cardiac arrhythmias, paraplegia, permanent neurological injury, and death. “In most of the cases reported to FDA, tranexamic acid injection was erroneously administered instead
Biologics
TG Therapeutics has begun a rolling BLA submission for ublituximab, a glycoengineered anti-CD20 monoclonal antibody, in combination with umbralisib, the company’s dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia. The submission is based on data from the UNITY-CLL
Devices
FDA says it has updated the SARS-CoV-2 reference panel comparative data on the agency Web site to reflect the latest information. An FDA notice says the reference panel is an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical
Drugs
FDA has approved a Vanda Pharmaceuticals NDA for Hetlioz (tasimelteon) capsule and liquid formulations for treating adults and children with nighttime sleep disturbances associated with Smith-Magenis Syndrome (SMS). The rare neurodevelopmental disorder, which involves an “inverted” circadian rhythm, makes it extremely difficult for patients with SMS to sleep during
FDA Policy/General
Federal Register notice: FDA has announced a 12/17 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss an emergency use authorization request by Moderna for its Covid-19 vaccine. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. They are: * Focus Groups as Used by the Food and Drug Administration * Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified and Thermally Processed Low-Acid Foods * Color Additive Certification Requests and
Drugs
FDA has approved an additional indication for Blueprint Medicine’s Gavreto (pralsetinib) to treat patients with advanced or metastatic RET-mutant and RET-fusion-positive thyroid cancer. The company says the accelerated approval expands the labeled instructions to include adult and pediatric patients age 12 or older with advanced or
Drugs
A 3/19/18-3/23/18 FDA inspection at West Coast Nuclear Pharmacy, Tampa, FL, found “serious deficiencies in your practices for producing sterile drug products, which put patients at risk.” A just-released 10/6 Warning Letter says that under current law, radiopharmaceuticals that are compounded by entities
Devices
FDA has published a Web page with answers to frequently asked questions relating to the development and use of transport media during the Covid-19 public health emergency. “These questions and answers provide additional clarity on existing policies and do not introduce any new policies or modify existing policies,” the
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